FDA 510(k) Application Details - K070457

Device Classification Name Dressing, Compression

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510(K) Number K070457
Device Name Dressing, Compression
Applicant SUN SCIENTIFIC LLC
543 LONG HILL AVENUE
SHELTON, CT 06484 US
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Contact JOSEPH AZARY
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Regulation Number 880.5075

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Classification Product Code MHW
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Date Received 02/16/2007
Decision Date 05/16/2007
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
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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