FDA 510(k) Application Details - K042062

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

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510(K) Number K042062
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant BARD PERIPHERAL VASCULAR, INC.
1625 WEST 3RD ST.
TEMPE, AZ 85281 US
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Contact SHARI ALLEN
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 08/02/2004
Decision Date 09/30/2004
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 Y
Expedited Review



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