The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Small Vessel Cannula.
Device ID | K760624 |
510k Number | K760624 |
Device Name: | SMALL VESSEL CANNULA |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-09-13 |
Decision Date | 1976-09-17 |