The following data is part of a premarket notification filed by Adroit Medical Systems, Inc. with the FDA for Soft-cover.
| Device ID | K921928 |
| 510k Number | K921928 |
| Device Name: | SOFT-COVER |
| Classification | Cover, Mattress (medical Purposes) |
| Applicant | ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
| Contact | Scott E Gammons |
| Correspondent | Scott E Gammons ADROIT MEDICAL SYSTEMS, INC. P.O. BOX 0984 Morganton, NC 28655 |
| Product Code | FMW |
| CFR Regulation Number | 880.6190 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-24 |
| Decision Date | 1992-11-06 |