Overshoes (Surchaussures
FDA 510(k) K851554 · Roseburg SA
510(k) numberK851554
Submission
- Device name
- Overshoes (Surchaussures
- Applicant
- Roseburg SA
Washington, DC, US - Received
- April 16, 1985
- Decision date
- April 30, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FXP – Cover, Shoe, Operating-Room
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4040
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code FXP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K971076 | Primed Shoe Covers, Primed Head CoversFXP · Traditional | Primeline Medical Products, Inc. | 01/13/1998SE |
| K971191 | Far-East Shoe CoversFXP · Traditional | Far East Science & Technology Development Co.… | 07/10/1997SE |
| K970815 | Convertors Impervious Shoe CoversFXP · Traditional | Allegiance Healthcare Corp. | 03/27/1997SE |
| K961342 | Shoe Cover, Non-SterileFXP · Traditional | Copioumed Intl., Inc. | 12/30/1996SE |
| K955835 | Fluid Barrier Boot Knee & Ankle-HighFXP · Traditional | Instrument Makar, Inc. | 11/19/1996SE |
| K952937 | Niomed Non-Skid Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K952897 | Niomed Shoe CoversFXP · Traditional | Amerasia Corp. | 10/23/1995SE |
| K943034 | Orex Shoe CoversFXP · Traditional | Thantex Specialties, Inc. | 01/02/1995SE |
| K932738 | Kappler Pro/Vent BootFXP · Traditional | Kappler, Inc. | 03/29/1994SE |
| K925815 | Reusable Liquidproof BootieFXP · Traditional | Amsco Sterile Recoveries, Inc. | 07/09/1993SE |
More from Amsco Sterile Recoveries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K931155 | Staple, Fixation Bone; Screw Fixation BoneHWC · Traditional | 09/01/1994SE |
| K890081 | Calius-Isabel Canovas SunglassesHQY · Traditional | 03/09/1989SE |
| K885275 | Assenat-Bleschet SunglassesHQY · Traditional | 01/24/1989SE |
| K882392 | Burnet Laboratoire Pharmaceutique Surgical GlovesKGO · Traditional | 08/26/1988SE |
| K872715 | Universal Instrumentation(Cd) for Spinal SurgeryJDN · Traditional | 12/07/1987SN |
| K874317 | Poirier Kid-Roller Manual WheelchairIOR · Traditional | 11/17/1987SE |
| K872714 | S.T.A.C.E.M. External Breast Prosthesis MammaryGBI · Traditional | 07/21/1987SE |
| K871689 | Spectacle Frame - LorraineHQZ · Traditional | 05/29/1987SE |
| K871688 | Spectacle Frame - DanielleHQZ · Traditional | 05/29/1987SE |
| K870654 | Efer ArthroscopeHRX · Traditional | 05/14/1987SE |
Questions and answers
When was Overshoes (Surchaussures cleared by the FDA?
Overshoes (Surchaussures (K851554) received a 510(k) decision of Substantially Equivalent on April 30, 1985, 14 days after the submission was received.
What is the product code of K851554?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.