FDA 510(k) Application Details - K143579

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

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510(K) Number K143579
Device Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Applicant NuVasive, Incorporated
7475 Lusk Boulevard
San Diego, CA 92121 US
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Contact Olga Lewis
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Regulation Number 880.6850

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Classification Product Code KCT
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Date Received 12/18/2014
Decision Date 08/28/2015
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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