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FDA 510(k) Application Details - K970863
Device Classification Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
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510(K) Number
K970863
Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Applicant
UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact
JONATHAN GILBERT
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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
03/10/1997
Decision Date
05/05/1997
Decision
SN - Substantially Equivalent for Some Indications
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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