The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Cannlula System.
Device ID | K862778 |
510k Number | K862778 |
Device Name: | HALL CANNLULA 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 | 1986-07-22 |
Decision Date | 1986-09-08 |