The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Clini-care + Pressure Ulcer Treatment System.
| Device ID | K882092 |
| 510k Number | K882092 |
| Device Name: | CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter Powell |
| Correspondent | Peter Powell GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-19 |
| Decision Date | 1988-07-13 |