The following data is part of a premarket notification filed by Brevet, Inc. with the FDA for Brevet Floss Pick (autoclave Sterilizer).
Device ID | K895958 |
510k Number | K895958 |
Device Name: | BREVET FLOSS PICK (AUTOCLAVE STERILIZER) |
Classification | Burnisher, Operative |
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 | EKJ |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-11 |
Decision Date | 1989-12-04 |