The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Modified Ham's F-10 Medium And Medium-hepes.
| Device ID | K900316 |
| 510k Number | K900316 |
| Device Name: | MODIFIED HAM'S F-10 MEDIUM AND MEDIUM-HEPES |
| Classification | Cap, Cervical |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Paul Weathersbee |
| Correspondent | Paul 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 | 1990-01-23 |
| Decision Date | 1990-04-16 |