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FDA 510(k) Application Details - K000539
Device Classification Name
Suture, Nonabsorbable, Synthetic, Polyamide
More FDA Info for this Device
510(K) Number
K000539
Device Name
Suture, Nonabsorbable, Synthetic, Polyamide
Applicant
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET, NY 11791 US
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Contact
RICHARD KUO
Other 510(k) Applications for this Contact
Regulation Number
878.5020
More FDA Info for this Regulation Number
Classification Product Code
GAR
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More FDA Info for this Product Code
Date Received
02/17/2000
Decision Date
04/27/2000
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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