The following data is part of a premarket notification filed by Lake Medical Products, Inc. with the FDA for Stage Zero Air Flotation Bed.
Device ID | K905053 |
510k Number | K905053 |
Device Name: | STAGE ZERO AIR FLOTATION BED |
Classification | Bed, Flotation Therapy, Powered |
Applicant | LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
Contact | Eli Schachet |
Correspondent | Eli Schachet LAKE MEDICAL PRODUCTS, INC. 1145 MOOG DR. St. Louis, MO 63146 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-11-08 |
Decision Date | 1990-11-26 |