FDA 510(k) Application Details - K141854

Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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510(K) Number K141854
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant OSUNG MND CO., LTD
180 S. WESTERN AVENUE, #205
CARPENTERSVILLE, IL 60110 US
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Contact KIRAN SHEIKH
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 07/09/2014
Decision Date 10/29/2015
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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