The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Endomed Laparoscopy Instruments.
Device ID | K921686 |
510k Number | K921686 |
Device Name: | ENDOMED LAPAROSCOPY INSTRUMENTS |
Classification | Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | KNF |
CFR Regulation Number | 884.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-04-08 |
Decision Date | 1994-03-30 |