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 |