The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for 45 Degree Shaver.
| Device ID | K870882 |
| 510k Number | K870882 |
| Device Name: | 45 DEGREE SHAVER |
| Classification | Instrument, Cutting, Orthopedic |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Carol L Apple |
| Correspondent | Carol L Apple BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | HTZ |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-05 |
| Decision Date | 1987-03-23 |