510(k) K772060
- Device
- PROTECT IV GARD
- Applicant
- OMNICON MEDICAL CORP.
- 510(k) number
- K772060
- Product code
- FMP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-12-20
- Date received
- 1977-10-31
- Regulation
- 880.6450
- Classification name
- Protector, Skin Pressure
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code FMP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150243 | Invictus Medical GelShield | Invictus Medical, Inc. | 2015-05-01 |
| K951325 | COMFEEL PLUS PRESSURE RELIEF DRESSING | Richard Hamer Assoc., Inc. | 1995-07-31 |
| K934731 | MEDSURG STERILE IMAGING PRODUCTS | Medsurg Industries, Inc. | 1994-03-28 |
| K820584 | DECUBICARE PADS & ACCESSORIES | Abco Dealers, Inc. | 1982-03-25 |
| K812344 | HEEL OR ELBOW PROTECTOR | Fred Sammons, Inc. | 1981-09-11 |
| K811184 | SPENCO DERMAL PADS | Spenco Medical Corp. | 1981-05-20 |
| K802829 | SCANLAN VASCU-STATT | Scanlan Intl., Inc. | 1981-01-15 |
| K802185 | ARTERIAL BLOOD SAMPLING KIT | Current Technologies, Inc. | 1980-10-10 |
| K801694 | FLOTATION PAD FOR OPERATING TABLE | Action Products, Inc. | 1980-08-27 |
| K801195 | DERMALEX OR NATRAWOOL SKIN PRESSURE PROT | Stock Wild & Co. | 1980-06-09 |
| K792297 | SPAN AIDS KIT | American Hospital Supply Corp. | 1979-12-20 |
| K791709 | HEEL/ELBOW PROTECTORS | Fibre Formations, Inc. | 1979-09-24 |
| K790995 | CONTEX | Foam Tek, Inc. | 1979-06-11 |
| K781246 | FOAM COMFORT RINGS | Fibre Formations, Inc. | 1978-08-10 |
| K780171 | ELBOW PROTECTOR | Stat Medical Corp. | 1978-02-06 |
Legacy Summary#
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FDA Review#
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