Duralastic Sheeting II
FDA 510(k) K961057 · Rand Scientific Corp.
510(k) numberK961057
Submission
- Device name
- Duralastic Sheeting II
- Applicant
- Rand Scientific Corp.
Sacramento, CA, US - Received
- March 18, 1996
- Decision date
- May 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MIB – Elastomer, Silicone Block
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.3620
- Specialty
- Ear, Nose, Throat
- Implant
- Yes
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More from Implantech Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963856 | Rand Nasal PackingEMX · Traditional | 10/18/1996SE |
| K961081 | Spirit Ridge Silicone Carving BlockMIB · Traditional | 05/22/1996SE |
| K955777 | Pmma ClasicHPX · Traditional | 05/16/1996SE |
| K961124 | The NautilusFZE · Traditional | 04/19/1996SE |
| K961080 | Medial Malar ImplantLZK · Traditional | 04/19/1996SE |
| K961072 | Pec ImplantMIC · Traditional | 04/19/1996SE |
| K961071 | The Magnum Chin ImplantFWP · Traditional | 04/19/1996SE |
| K955366 | Trans-Aire Rigid Gas Permable Contact LensHQD · Traditional | 03/28/1996SE |
| K952165 | Trans-Aire Rigid Gas Permeable Contact LensHQD · Traditional | 06/30/1995SE |
Questions and answers
When was Duralastic Sheeting II cleared by the FDA?
Duralastic Sheeting II (K961057) received a 510(k) decision of Substantially Equivalent on May 16, 1996, 59 days after the submission was received.
What is the product code of K961057?
The FDA product code is MIB – Elastomer, Silicone Block, a Class II (moderate risk) device regulated under 21 CFR 874.3620.