The following data is part of a premarket notification filed by Hancock Laboratories, Inc. with the FDA for Hancock Aortic Punch.
Device ID | K800122 |
510k Number | K800122 |
Device Name: | HANCOCK AORTIC PUNCH |
Classification | Instruments, Surgical, Cardiovascular |
Applicant | HANCOCK LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DWS |
CFR Regulation Number | 870.4500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-01-18 |
Decision Date | 1980-02-01 |