The following data is part of a premarket notification filed by Hancock Laboratories, Inc. with the FDA for Modified Catheter Package.
Device ID | K800703 |
510k Number | K800703 |
Device Name: | MODIFIED CATHETER PACKAGE |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | HANCOCK LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-03-27 |
Decision Date | 1980-04-08 |