The following data is part of a premarket notification filed by Mellen Air Mfg., Inc. with the FDA for Aprema I - Alternating Pressure Air Flotation Mattress System.
| Device ID | K963510 |
| 510k Number | K963510 |
| Device Name: | APREMA I - ALTERNATING PRESSURE AIR FLOTATION MATTRESS SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | MELLEN AIR MFG., INC. 2840 TEMPLE AVE. Long Beach, CA 90806 |
| Contact | Bertrand H Weidberg |
| Correspondent | Bertrand H Weidberg MELLEN AIR MFG., INC. 2840 TEMPLE AVE. Long Beach, CA 90806 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-03 |
| Decision Date | 1996-11-26 |