K920649 is an FDA 510(k) clearance for the COMPASEP. This device is classified as a Patient Examination Glove (Class I - General Controls, product code FMC).
Submitted by Wilde-USA, Inc. (Chicago, US). The FDA issued a Cleared decision on July 23, 1992, 162 days after receiving the submission on February 12, 1992.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250.
| 510(k) Number | K920649 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 1992 |
| Decision Date | July 23, 1992 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | FMC — Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |