The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Scm-3 And Accessories.
| Device ID | K914921 |
| 510k Number | K914921 |
| Device Name: | SCM-3 AND ACCESSORIES |
| Classification | Mattress, Flotation Therapy, Non-powered |
| 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 | IKY |
| CFR Regulation Number | 880.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-04 |
| Decision Date | 1992-03-12 |