The following data is part of a premarket notification filed by Brevet, Inc. with the FDA for Brevet Cassette Sterilization Module.
Device ID | K882617 |
510k Number | K882617 |
Device Name: | BREVET CASSETTE STERILIZATION MODULE |
Classification | Tray, Surgical, Instrument |
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 | FSM |
CFR Regulation Number | 878.4800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-24 |
Decision Date | 1988-07-28 |