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FDA 510(k) Application Details - K960209
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polypropylene
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510(K) Number
K960209
Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Applicant
CUSTOM PACK RELIABILITY
4207 VINELAND ROAD, M-1
ORLANDO, FL 32811 US
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Contact
RICHARD L ELLWOOD
Other 510(k) Applications for this Contact
Regulation Number
878.5010
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Classification Product Code
GAW
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More FDA Info for this Product Code
Date Received
01/16/1996
Decision Date
04/04/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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