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FDA 510(k) Application Details - K970266
Device Classification Name
Dressing, Wound, Collagen
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510(K) Number
K970266
Device Name
Dressing, Wound, Collagen
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD, MA 02048 US
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Contact
DAVID A OLSON
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Regulation Number
000.0000
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Classification Product Code
KGN
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More FDA Info for this Product Code
Date Received
01/23/1997
Decision Date
04/23/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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