The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Sternal Power Awl.
| Device ID | K873766 |
| 510k Number | K873766 |
| Device Name: | STERNAL POWER AWL |
| Classification | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Susan Brandt |
| Correspondent | Susan Brandt BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | KIJ |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-09-16 |
| Decision Date | 1988-11-14 |