FDA 510(k) Application Details - K133942

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

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510(K) Number K133942
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant INTUITIVE SURGICAL
1266 KIFER ROAD
SUNNYVALE, CA 94086 US
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Contact BRANDON HANSEN
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 12/23/2013
Decision Date 08/01/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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