510(k) K051157

INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS by Micromedics, Inc. — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2005
Date Received
May 5, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class
Class II
Regulation Number
880.6850
Review Panel
HO
Submission Type