The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Dunbar Drill Guide System.
| Device ID | K864163 |
| 510k Number | K864163 |
| Device Name: | HALL DUNBAR DRILL GUIDE SYSTEM |
| Classification | Arthroscope |
| Applicant | HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara, CA 93102 |
| Contact | David D Wellington |
| Correspondent | David D Wellington HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara, CA 93102 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-23 |
| Decision Date | 1986-11-20 |