The following data is part of a premarket notification filed by Cunningham Woodland, Inc. with the FDA for Subclavian Insertion Kit.
Device ID | K823527 |
510k Number | K823527 |
Device Name: | SUBCLAVIAN INSERTION KIT |
Classification | Syringe, Piston |
Applicant | CUNNINGHAM WOODLAND, INC. MA |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-30 |
Decision Date | 1983-03-31 |