The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Sof. Care Cushion & Sof-care Cushion Cover.
| Device ID | K851027 |
| 510k Number | K851027 |
| Device Name: | SOF. CARE CUSHION & SOF-CARE CUSHION COVER |
| Classification | Cushion, Flotation |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | John Phillips |
| Correspondent | John Phillips GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-12 |
| Decision Date | 1985-06-18 |