The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Flushflo Ii.
| Device ID | K812173 |
| 510k Number | K812173 |
| Device Name: | FLUSHFLO II |
| Classification | Catheter, Continuous Flush |
| Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-08-03 |
| Decision Date | 1981-08-18 |