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 |