The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Screw Removal Trephine.
Device ID | K882008 |
510k Number | K882008 |
Device Name: | ACE SCREW REMOVAL TREPHINE |
Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | HWE |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-13 |
Decision Date | 1988-06-10 |