The following data is part of a premarket notification filed by American V. Mueller with the FDA for V. Mueller Pheumo-intestinal Instrument Set.
Device ID | K844628 |
510k Number | K844628 |
Device Name: | V. MUELLER PHEUMO-INTESTINAL INSTRUMENT SET |
Classification | Stapler, Surgical |
Applicant | AMERICAN V. MUELLER 6600 W. TOUHY Chicago, IL 60648 |
Contact | Matthew Nowland |
Correspondent | Matthew 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 | 1984-11-27 |
Decision Date | 1984-12-14 |