The following data is part of a premarket notification filed by American Bentley with the FDA for Amer. Bentley Hemofilter Holder Hfh-1.
| Device ID | K843504 |
| 510k Number | K843504 |
| Device Name: | AMER. BENTLEY HEMOFILTER HOLDER HFH-1 |
| Classification | Set, Dialyzer Holder |
| Applicant | AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Contact | Donald A Raible |
| Correspondent | Donald A Raible AMERICAN BENTLEY 17502 ARMSTRONG AVE. Irvine, CA 92714 |
| Product Code | FKI |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-06 |
| Decision Date | 1984-10-18 |