The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Irrigation System.
| Device ID | K852143 |
| 510k Number | K852143 |
| Device Name: | HALL IRRIGATION SYSTEM |
| Classification | Catheter, Irrigation |
| 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 | GBX |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-16 |
| Decision Date | 1985-06-26 |