The following data is part of a premarket notification filed by American V. Mueller with the FDA for V-mueller Inverted Linear Anastomosis Instruments.
Device ID | K850947 |
510k Number | K850947 |
Device Name: | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS |
Classification | Stapler, Surgical |
Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Contact | Mathew Nowland |
Correspondent | Mathew Nowland AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Product Code | GAG |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-07 |
Decision Date | 1985-04-17 |