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FDA 510(k) Application Details - K980065
Device Classification Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
More FDA Info for this Device
510(K) Number
K980065
Device Name
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant
C/T MED SYSTEM, LTD.
3755 NORTH ARLINGTON AVE.
INDIANAPOIS, IN 46218 US
Other 510(k) Applications for this Company
Contact
ALAN BOOKER
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
KCT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/07/1998
Decision Date
05/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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