FDA 510(k) Application Details - K962545

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

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510(K) Number K962545
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant STERILIZATION CASSETTE SYSTEMS, INC.
435 E. MAIN, STE. A-6
GREENWOOD, IN 46143 US
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Contact STEPHEN F SPENCER
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 06/28/1996
Decision Date 03/07/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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