The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Sof. Press Epc 51 System.
| Device ID | K963067 |
| 510k Number | K963067 |
| Device Name: | SOF. PRESS EPC 51 SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter J Scott |
| Correspondent | Peter J Scott GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-07 |
| Decision Date | 1997-01-28 |
| Summary: | summary |