The following data is part of a premarket notification filed by Steridyne Corp. with the FDA for Zero-g(tm) Gel/foam Mattress Topper.
| Device ID | K911843 |
| 510k Number | K911843 |
| Device Name: | ZERO-G(TM) GEL/FOAM MATTRESS TOPPER |
| Classification | Cushion, Flotation |
| Applicant | STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
| Contact | Mark P Poncy |
| Correspondent | Mark P Poncy STERIDYNE CORP. 3725 INVESTMENT LN. Riviera Beach, FL 33404 |
| Product Code | KIC |
| CFR Regulation Number | 890.3175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-25 |
| Decision Date | 1991-05-30 |