Spyroflex Pigmented Wound Dressing
FDA 510(k) K963623 · Polymedica Industries, Inc.
510(k) numberK963623
Submission
- Device name
- Spyroflex Pigmented Wound Dressing
- Applicant
- Polymedica Industries, Inc.
Golden,, CO, US - Received
- September 11, 1996
- Decision date
- October 25, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGP – Dressing, Wound And Burn, Occlusive
- Device class
- Unclassified
Other 510(k)s with product code MGP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K012997 | Collatek FoamMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K012995 | Collatek SheetMGP · Traditional | Biocore Medical Technologies, Inc. | 10/25/2001SE |
| K001508 | Laserskin DressingMGP · Traditional | Fidia Advanced Biopolymers Srl | 07/25/2001SE |
| K990079 | Fastseal Chest Wound DressingMGP · Traditional | Greenfield Medical Technologies, Inc. | 12/23/1999SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | Hollister, Inc. | 10/14/1999SE |
| K992302 | Dermaphylyx Skin Protectors, Protect It Skin ProtectorsMGP · Traditional | Dermaphylyx, Inc. | 09/14/1999SE |
| K992005 | Giltech Plus Transparent DressingMGP · Traditional | Giltech Plus, Inc. | 09/03/1999SE |
| K990875 | Dermaphylyx Film Wound Dressing and Healian Film Wound DressingMGP · Traditional | Dermaphylyx, Inc. | 05/27/1999SN |
| K990438 | Dermaflex Wound Dressing, Dermaflex Foam Wound Dressing, Healiaflex Wound Dressing…MGP · Traditional | Dermaphylyx, Inc. | 03/25/1999SE |
| K984371 | Mepitel Non Adherent Silicone DressingMGP · Traditional | Molnlycke Health Care, Inc. | 03/03/1999SE |
More from Molnlycke Health Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964398 | Spyroflex Pigmented Wound Dressing/Spyroflex Wound Dressing TintedMGP · Traditional | 10/24/1997SE |
| K971045 | Basis Flexible Tip Digital ThermometerFLL · Traditional | 05/02/1997SE |
| K964701 | Mitraflex Pigmented Wound DressingFRO · Traditional | 02/07/1997SE |
| K962991 | Basis Baby-Temp Pacifier Digital TherometerFLL · Traditional | 09/12/1996SE |
| K955383 | Spyrocolloid Wound DressingMGP · Traditional | 12/13/1995SN |
| K953885 | Spyroflex Skin ProtectorMGP · Traditional | 11/29/1995SE |
| K952756 | Medi-Aid Basal ThermometerLHD · Traditional | 09/25/1995SE |
| K952159 | Basis Digital ThermometerFLL · Traditional | 09/22/1995SE |
| K953618 | Spyroflex Wound DressingMGP · Traditional | 08/21/1995SN |
| K951862 | A Gel Wound DressingMGQ · Traditional | 07/12/1995SE |
Questions and answers
When was Spyroflex Pigmented Wound Dressing cleared by the FDA?
Spyroflex Pigmented Wound Dressing (K963623) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 44 days after the submission was received.
What is the product code of K963623?
The FDA product code is MGP – Dressing, Wound And Burn, Occlusive, a Unclassified device.