The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Sperm Washing Medium #9932.
| Device ID | K872102 |
| 510k Number | K872102 |
| Device Name: | SPERM WASHING MEDIUM #9932 |
| Classification | Cap, Cervical |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | S Weathersbee |
| Correspondent | S Weathersbee IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | HDR |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-01 |
| Decision Date | 1987-07-16 |