The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace/williams Microsurgery Saw System.
Device ID | K902525 |
510k Number | K902525 |
Device Name: | ACE/WILLIAMS MICROSURGERY SAW SYSTEM |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Contact | W Schlerf |
Correspondent | W Schlerf BUCKMAN CO., INC. 1000 BURNETT AVE. SUITE 450 Concord, CA 94520 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-06-05 |
Decision Date | 1990-11-26 |