P.S.M. Justa Cover
FDA 510(k) K761072 · The Owenby Co.
510(k) numberK761072
Submission
- Device name
- P.S.M. Justa Cover
- Applicant
- The Owenby Co.
Mchenry, IL, US - Received
- November 16, 1976
- Decision date
- December 2, 1976
- 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 |
|---|---|---|
| K801628 | Restraint, ProtectiveIQK · Traditional | 08/07/1980SE |
| K801627 | Cover, LimbIPM · Traditional | 07/28/1980SE |
| K801626 | Arm SlingILI · Traditional | 07/28/1980SE |
| K801532 | Stockinette, Sterile Two Ply W/Pull TabsFQM · Traditional | 07/28/1980SE |
| K801531 | Arm SlingILI · Traditional | 07/21/1980SE |
| K790210 | Stockinette, Tubular UnbleachedFQM · Traditional | 02/27/1979SE |
| K780764 | Non-Sterile Folded GauzeNAB · Traditional | 06/06/1978SE |
| K780418 | Burn Dressing PadFPY · Traditional | 04/10/1978SE |
| K770889 | Burn Dressing KitEFQ · Traditional | 07/11/1977SE |
| K761071 | P.S.M. Justa KapFYF · Traditional | 12/30/1976SE |
Questions and answers
When was P.S.M. Justa Cover cleared by the FDA?
P.S.M. Justa Cover (K761072) received a 510(k) decision of Substantially Equivalent on December 2, 1976, 16 days after the submission was received.
What is the product code of K761072?
The FDA product code is FXP – Cover, Shoe, Operating-Room, a Class I (low risk) device regulated under 21 CFR 878.4040.