The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Disposable 45 Degree Shaver.
| Device ID | K896538 |
| 510k Number | K896538 |
| Device Name: | DISPOSABLE 45 DEGREE SHAVER |
| Classification | Arthroscope |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Pamela Gasper |
| Correspondent | Pamela Gasper BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-16 |
| Decision Date | 1989-12-06 |