The following data is part of a premarket notification filed by Hall Surgical, Division Of Zimmer, Inc. with the FDA for Hall Sternum Saw.
Device ID | K862474 |
510k Number | K862474 |
Device Name: | HALL STERNUM SAW |
Classification | Blade, Saw, Surgical, Cardiovascular |
Applicant | HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara, CA 93102 |
Contact | David Wellington |
Correspondent | David Wellington HALL SURGICAL, DIVISION OF ZIMMER, INC. P.O. BOX 899 `anta Barbara, CA 93102 |
Product Code | DWH |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-30 |
Decision Date | 1986-07-17 |