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FDA 510(k) Application Details - K043296
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K043296
Device Name
Dressing, Wound, Drug
Applicant
COVALON TECHNOLOGIES, INC.
14510 KANDI COURT
LARGO, FL 33774 US
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Contact
PAUL L GUILBAUD
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
11/29/2004
Decision Date
06/06/2005
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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