The following data is part of a premarket notification filed by Buckman Co., Inc. with the FDA for Ace Orthopaedic Washers.
| Device ID | K895107 |
| 510k Number | K895107 |
| Device Name: | ACE ORTHOPAEDIC WASHERS |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-09-11 |