FDA 510(k) Application Details - K102403

Device Classification Name Dressing,Wound,Occlusive

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510(K) Number K102403
Device Name Dressing,Wound,Occlusive
Applicant SAM MEDICAL PRODUCTS
27350 SW 95th Ave Ste 3038 Bldg 30
Wilsonville, OR 97070 US
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Contact JACK N MCCUTCHEON
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Regulation Number 878.4020

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Classification Product Code NAD
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Date Received 08/24/2010
Decision Date 03/03/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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