The following data is part of a premarket notification filed by Biologics Intl., Inc. with the FDA for Air Bed & Flotation Dermagard 800 & 900 Systems.
| Device ID | K882229 |
| 510k Number | K882229 |
| Device Name: | AIR BED & FLOTATION DERMAGARD 800 & 900 SYSTEMS |
| Classification | Bed, Flotation Therapy, Powered |
| Applicant | BIOLOGICS INTL., INC. P.O. BOX 307 Indian Rocks Beach, FL 34635 -0307 |
| Contact | Mark A Hagopian |
| Correspondent | Mark A Hagopian BIOLOGICS INTL., INC. P.O. BOX 307 Indian Rocks Beach, FL 34635 -0307 |
| Product Code | IOQ |
| CFR Regulation Number | 890.5170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-05-20 |
| Decision Date | 1988-08-16 |