The following data is part of a premarket notification filed by Brevet, Inc. with the FDA for Small Instrument Sterilization/bur Box.
Device ID | K910794 |
510k Number | K910794 |
Device Name: | SMALL INSTRUMENT STERILIZATION/BUR BOX |
Classification | Bur, Dental |
Applicant | BREVET, INC. 3630 MIRALOMA P.O. BOX 17713 Anahem, CA 92806 |
Contact | Timothy Diamond |
Correspondent | Timothy Diamond BREVET, INC. 3630 MIRALOMA P.O. BOX 17713 Anahem, CA 92806 |
Product Code | EJL |
CFR Regulation Number | 872.3240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-25 |
Decision Date | 1991-05-23 |