FDA 510(k) Application Details - K960585

Device Classification Name Kit, Wound Dressing

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510(K) Number K960585
Device Name Kit, Wound Dressing
Applicant SUNCOAST MEDICAL PRODUCTS, INC.
911 LAKESIDE DR.
CARGO, FL 33778 US
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Contact JACK S BOROWSKY
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Regulation Number 000.0000

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Classification Product Code MCY
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Date Received 02/12/1996
Decision Date 04/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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