The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Sterile Bur.
Device ID | K862529 |
510k Number | K862529 |
Device Name: | HALL STERILE BUR |
Classification | Burr, Orthopedic |
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 | HTT |
CFR Regulation Number | 888.4540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-02 |
Decision Date | 1986-07-15 |