The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Orthochuck.
Device ID | K964252 |
510k Number | K964252 |
Device Name: | ORTHOCHUCK |
Classification | Motor, Surgical Instrument, Ac-powered |
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 | GEY |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-10-24 |
Decision Date | 1997-05-27 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ORTHOCHUCK 73673009 1482149 Dead/Cancelled |
FLYNN, JEROME R. 1987-07-20 |