The following data is part of a premarket notification filed by Wilde-usa, Inc. with the FDA for Compasep.
| Device ID | K920649 |
| 510k Number | K920649 |
| Device Name: | COMPASEP |
| Classification | Patient Examination Glove |
| Applicant | WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer WILDE-USA, INC. 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Product Code | FMC |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-12 |
| Decision Date | 1992-07-23 |