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FDA 510(k) Application Details - K033164
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K033164
Device Name
Dressing, Wound, Drug
Applicant
DR. LEN'S MEDICAL PRODUCTS LLC
1308 MORNINGSIDE PARK DRIVE
ALPHARETTA, GA 30022 US
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Contact
JAY MANSOUR
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
09/30/2003
Decision Date
09/07/2004
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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