The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Vessel Retractor, #600732.
Device ID | K802244 |
510k Number | K802244 |
Device Name: | VESSEL RETRACTOR, #600732 |
Classification | Clamp, Vascular |
Applicant | BENTLEY LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DXC |
CFR Regulation Number | 870.4450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-16 |
Decision Date | 1980-10-03 |