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510(k) K112087

TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS by Advanced Sterilization Products — Product Code KCT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2012
Date Received
July 21, 2011
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

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