The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Glenoid Drill.
| Device ID | K863147 |
| 510k Number | K863147 |
| Device Name: | GLENOID DRILL |
| Classification | Bit, Drill |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Carl Apple |
| Correspondent | Carl Apple BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | HTW |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-15 |
| Decision Date | 1986-09-05 |