The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Sperm Capacitation Medium.
| Device ID | K861188 |
| 510k Number | K861188 |
| Device Name: | SPERM CAPACITATION MEDIUM |
| Classification | Cap, Cervical |
| Applicant | IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills, CA 92653 |
| Contact | Newman Assoc. |
| Correspondent | Newman Assoc. IRVINE SCIENTIFIC CHARLES H. NEWMAN 25283 CABOT ROAD, STE. 207 Laguna Hills, CA 92653 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-31 |
| Decision Date | 1987-01-06 |