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FDA 510(k) Application Details - K071111
Device Classification Name
Suture, Nonabsorbable, Silk
More FDA Info for this Device
510(K) Number
K071111
Device Name
Suture, Nonabsorbable, Silk
Applicant
ARROW INTL., INC.
2400 BERNVILLE RD.
READING, PA 19605 US
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Contact
KARL J NITTINGER
Other 510(k) Applications for this Contact
Regulation Number
878.5030
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Classification Product Code
GAP
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More FDA Info for this Product Code
Date Received
04/20/2007
Decision Date
07/17/2007
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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