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FDA 510(k) Application Details - K082330
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K082330
Device Name
Dressing, Wound, Drug
Applicant
PRIMARY CARE SOLUTIONS, INC.
40420 FREE FALL AVE.
ZEPHYRHILLS, FL 33542 US
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Contact
RON MADDIX
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/14/2008
Decision Date
10/09/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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