The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Htf With Albumin (catalog No. 9994).
| Device ID | K894405 |
| 510k Number | K894405 |
| Device Name: | HTF WITH ALBUMIN (CATALOG NO. 9994) |
| Classification | Cap, Cervical |
| Applicant | IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana, CA 92705 |
| Contact | Paul Weathersbee,phd |
| Correspondent | Paul Weathersbee,phd 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 | 1989-07-17 |
| Decision Date | 1989-09-22 |