The following data is part of a premarket notification filed by American Bentley with the FDA for Dosimetric Release Of Rad. Tubing Pac.
| Device ID | K833047 |
| 510k Number | K833047 |
| Device Name: | DOSIMETRIC RELEASE OF RAD. TUBING PAC |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1985-06-11 |