The following data is part of a premarket notification filed by Danninger Medical Technology, Inc. with the FDA for Danninger Orthopaedic Awl.
| Device ID | K875223 |
| 510k Number | K875223 |
| Device Name: | DANNINGER ORTHOPAEDIC AWL |
| Classification | Awl |
| Applicant | DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Contact | David Schlerf |
| Correspondent | David Schlerf DANNINGER MEDICAL TECHNOLOGY, INC. C/O BUCKMAN CO., INC. 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Product Code | HWJ |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-22 |
| Decision Date | 1988-02-17 |