The following data is part of a premarket notification filed by Maverick Surgical, Inc. with the FDA for Holder, Dental Bur, Aluminum.
Device ID | K904278 |
510k Number | K904278 |
Device Name: | HOLDER, DENTAL BUR, ALUMINUM |
Classification | Syringe, Cartridge |
Applicant | MAVERICK SURGICAL, INC. 16940 - 87 AVENUE Edmonton, Alberta, CA T5r 4h5 |
Contact | Ken Kehoe |
Correspondent | Ken Kehoe MAVERICK SURGICAL, INC. 16940 - 87 AVENUE Edmonton, Alberta, CA T5r 4h5 |
Product Code | EJI |
CFR Regulation Number | 872.6770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-17 |
Decision Date | 1990-11-02 |