The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Quick Prime Hemoconcen. No. Hq-7000 And Cbp-7000q.
| Device ID | K903641 |
| 510k Number | K903641 |
| Device Name: | QUICK PRIME HEMOCONCEN. NO. HQ-7000 AND CBP-7000Q |
| Classification | Dialyzer, High Permeability With Or Without Sealed Dialysate System |
| Applicant | BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Contact | Donald Railbe |
| Correspondent | Donald Railbe BENTLEY LABORATORIES, INC. P.O. BIX 19522 Irvine, CA 92713 |
| Product Code | KDI |
| CFR Regulation Number | 876.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-14 |
| Decision Date | 1990-11-09 |