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FDA 510(k) Application Details - K050177
Device Classification Name
Dressing, Wound, Collagen
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510(K) Number
K050177
Device Name
Dressing, Wound, Collagen
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
KGN
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More FDA Info for this Product Code
Date Received
01/26/2005
Decision Date
04/27/2005
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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