The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Sperm Maintenance Medium With Glycerol.
| Device ID | K914541 |
| 510k Number | K914541 |
| Device Name: | SPERM MAINTENANCE MEDIUM WITH GLYCEROL |
| Classification | Cannula, Intrauterine Insemination |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Paul S Weathersbee |
| Correspondent | Paul S Weathersbee IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Product Code | MFD |
| CFR Regulation Number | 884.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-11 |
| Decision Date | 1994-02-03 |