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FDA 510(k) Application Details - K000542
Device Classification Name
Suture, Absorbable, Natural
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510(K) Number
K000542
Device Name
Suture, Absorbable, Natural
Applicant
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET, NY 11791 US
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Contact
RICHARD KUO
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Regulation Number
878.4830
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Classification Product Code
GAL
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More FDA Info for this Product Code
Date Received
02/17/2000
Decision Date
04/28/2000
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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