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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
Other 510(k) Applications for this Contact
Regulation Number
000.0000
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Classification Product Code
MCY
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More FDA Info for this Product Code
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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