The following data is part of a premarket notification filed by Creative Medical, Inc. with the FDA for Stage Iv, Cm-4000,mattress Overlay System.
| Device ID | K933091 |
| 510k Number | K933091 |
| Device Name: | STAGE IV, CM-4000,MATTRESS OVERLAY SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | CREATIVE MEDICAL, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Contact | Milton Beneke |
| Correspondent | Milton Beneke CREATIVE MEDICAL, INC. 55 NORTHERN BLVD. SUITE 410 Great Neck, NY 11021 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-24 |
| Decision Date | 1993-12-21 |