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 |