The following data is part of a premarket notification filed by Sartorius Filters, Inc. with the FDA for Sartorius Minisart Fh 16534.
| Device ID | K851816 |
| 510k Number | K851816 |
| Device Name: | SARTORIUS MINISART FH 16534 |
| Classification | Filter, Infusion Line |
| Applicant | SARTORIUS FILTERS, INC. 30940 SAN CLEMENTE ST. Hayward, CA 94544 |
| Contact | Steven Cates |
| Correspondent | Steven Cates SARTORIUS FILTERS, INC. 30940 SAN CLEMENTE ST. Hayward, CA 94544 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-08-19 |