FMP — Protector, Skin Pressure Class I
FDA product code FMP covers "Protector, Skin Pressure", a Class I medical device regulated under 21 CFR 880.6450. Submissions are reviewed by the General Hospital panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FMP
- Device Class
- Class I
- Regulation Number
- 880.6450
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150243 | Invictus Medical | Invictus Medical GelShield | May 1, 2015 |
| K951325 | Richard Hamer Assoc | COMFEEL PLUS PRESSURE RELIEF DRESSING | Jul 31, 1995 |
| K934731 | Medsurg Industries | MEDSURG STERILE IMAGING PRODUCTS | Mar 28, 1994 |
| K820584 | Abco Dealers | DECUBICARE PADS & ACCESSORIES | Mar 25, 1982 |
| K812344 | Fred Sammons | HEEL OR ELBOW PROTECTOR | Sep 11, 1981 |
| K811184 | Spenco Medical | SPENCO DERMAL PADS | May 20, 1981 |
| K802829 | Scanlan Intl | SCANLAN VASCU-STATT | Jan 15, 1981 |
| K802185 | Current Technologies | ARTERIAL BLOOD SAMPLING KIT | Oct 10, 1980 |
| K801694 | Action Products | FLOTATION PAD FOR OPERATING TABLE | Aug 27, 1980 |
| K801195 | Stock Wild And | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Jun 9, 1980 |
| K792297 | American Hospital Supply | SPAN AIDS KIT | Dec 20, 1979 |
| K791709 | Fibre Formations | HEEL/ELBOW PROTECTORS | Sep 24, 1979 |
| K790995 | Foam Tek | CONTEX | Jun 11, 1979 |
| K781246 | Fibre Formations | FOAM COMFORT RINGS | Aug 10, 1978 |
| K780171 | Stat Medical | ELBOW PROTECTOR | Feb 6, 1978 |
| K772419 | Fred Sammons | HEEL OR ELBOW PROTECTOR | Jan 26, 1978 |
| K772060 | Omnicon Medical | PROTECT IV GARD | Dec 20, 1977 |
| K771913 | Alba-Waldensian | HEEL/ELBOW PROTECTOR | Nov 15, 1977 |
| K771633 | Medical Restraints | HEEL PROTECTOR | Sep 12, 1977 |
| K771519 | Johnson And Johnson Professionals | SPECIALIST ARM & LEG PROTECTOR | Aug 26, 1977 |