The following data is part of a premarket notification filed by Bentley Laboratories, Inc. with the FDA for Quick Prime Lines, #'s Bpl-12, Bpl-48 &.
Device ID | K802378 |
510k Number | K802378 |
Device Name: | QUICK PRIME LINES, #'S BPL-12, BPL-48 & |
Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
Applicant | BENTLEY LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWF |
CFR Regulation Number | 870.4210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-09-30 |
Decision Date | 1980-10-10 |