The following data is part of a premarket notification filed by Tava Surgical Instruments with the FDA for Surgical Bur.
Device ID | K872475 |
510k Number | K872475 |
Device Name: | SURGICAL BUR |
Classification | Bur, Surgical, General & Plastic Surgery |
Applicant | TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Contact | Terry M Mattchen |
Correspondent | Terry M Mattchen TAVA SURGICAL INSTRUMENTS 7756 BURNETT AVE. Van Nuys, CA 91405 |
Product Code | GFF |
CFR Regulation Number | 878.4820 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-23 |
Decision Date | 1987-07-02 |