The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Lake Stagezero(tm) Air Flotation Bed.
| Device ID | K943162 |
| 510k Number | K943162 |
| Device Name: | LAKE STAGEZERO(TM) AIR FLOTATION BED |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | LAKE MEDICAL PRODUCTS, INC. 1588 ROUTE 130, SUITE C-2 North Brunswick, NJ 08902 |
| Contact | Patricia W Bradstreet |
| Correspondent | Patricia W Bradstreet LAKE MEDICAL PRODUCTS, INC. 1588 ROUTE 130, SUITE C-2 North Brunswick, NJ 08902 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-01 |
| Decision Date | 1995-02-27 |