The following data is part of a premarket notification filed by Gaymar Industries, Inc. with the FDA for Spr Plus Ii Overlay System (cl250/cl212.
| Device ID | K961854 |
| 510k Number | K961854 |
| Device Name: | SPR PLUS II OVERLAY SYSTEM (CL250/CL212 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | GAYMAR INDUSTRIES, INC. 10 CENTRE DR. Orchard Park, NY 14127 |
| Contact | Peter Scott |
| Correspondent | Peter Scott 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 | 1996-05-14 |
| Decision Date | 1996-08-09 |
| Summary: | summary |