The following data is part of a premarket notification filed by Bowen & Company, Inc. with the FDA for Bowen Knot Passer.
| Device ID | K863148 |
| 510k Number | K863148 |
| Device Name: | BOWEN KNOT PASSER |
| Classification | Passer, Wire, Orthopedic |
| Applicant | BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Contact | Carol Apple |
| Correspondent | Carol Apple BOWEN & COMPANY, INC. 1800 CHAPMAN AVE. Rockville, MD 20852 |
| Product Code | HXI |
| 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 |