FDA 510(k) Application Details - K103210

Device Classification Name Wrap, Sterilization

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510(K) Number K103210
Device Name Wrap, Sterilization
Applicant ADVANCED STERILIZATION PRODUCTS
33 TECHNOLOGY DR.
IRVINE, CA 92618 US
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Contact NANCY CHU
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Regulation Number 880.6850

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Classification Product Code FRG
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Date Received 11/01/2010
Decision Date 06/06/2011
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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