The following data is part of a premarket notification filed by Sybron Dental Specialties with the FDA for Steri-cassette And Steri-cage Sterilization Packaging System.
Device ID | K162063 |
510k Number | K162063 |
Device Name: | Steri-Cassette And Steri-Cage Sterilization Packaging System |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | Sybron Dental Specialties 1717 W. Collins Ave. Orange, CA 92867 |
Contact | Jennifer Dzidrums |
Correspondent | Jennifer Dzidrums Sybron Dental Specialties 1717 W. Collins Ave. Orange, CA 92867 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-26 |
Decision Date | 2017-04-21 |
Summary: | summary |