The following data is part of a premarket notification filed by United Medical Systems, Inc. with the FDA for Sqa.
| Device ID | K894949 |
| 510k Number | K894949 |
| Device Name: | SQA |
| Classification | Semen Analysis Device |
| Applicant | UNITED MEDICAL SYSTEMS, INC. MACKLER AND GIBBS, P.C. 1120 VERMONT AVE., STE 600 Washington, DC 20005 |
| Contact | Bruce F Mackler |
| Correspondent | Bruce F Mackler UNITED MEDICAL SYSTEMS, INC. MACKLER AND GIBBS, P.C. 1120 VERMONT AVE., STE 600 Washington, DC 20005 |
| Product Code | POV |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-03 |
| Decision Date | 1989-12-29 |