The following data is part of a premarket notification filed by American Bentley with the FDA for Use Of Tween 80 As A Wetting Agent On.
| Device ID | K832802 |
| 510k Number | K832802 |
| Device Name: | USE OF TWEEN 80 AS A WETTING AGENT ON |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | AMERICAN BENTLEY 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-18 |
| Decision Date | 1983-12-29 |