The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Hasting Finger Fixator Instruments.
| Device ID | K880046 |
| 510k Number | K880046 |
| Device Name: | HASTING FINGER FIXATOR INSTRUMENTS |
| Classification | Brace, Drill |
| 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 | HXY |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-06 |
| Decision Date | 1988-02-16 |