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FDA 510(k) Application Details - K061796
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K061796
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
VYGON CORP.
30833 NORTHWESTERS HWY
SUITE 121
FARMINGTON HILLS, MI 48334 US
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Contact
STEPHEN GOLDNER
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Regulation Number
878.4493
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Classification Product Code
GAM
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More FDA Info for this Product Code
Date Received
06/26/2006
Decision Date
11/02/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
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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