The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Beaded K-wires Ace Olive Wires.
Device ID | K895079 |
510k Number | K895079 |
Device Name: | ACE BEADED K-WIRES ACE OLIVE WIRES |
Classification | Pin, Fixation, Smooth |
Applicant | BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David Schlerf |
Correspondent | David Schlerf BUCKMAN CO., INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | HTY |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-08-14 |
Decision Date | 1989-09-13 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00887868001512 | K895079 | 000 |
00887868001505 | K895079 | 000 |
00887868001482 | K895079 | 000 |