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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K000540
Device Name POLYESTER NONABSORBABLE SURGICAL SUTURES, USP
Applicant
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET,  NY  11791
Applicant Contact RICHARD KUO
Correspondent
ARC MEDICAL SUPPLIES (BEIJING) CO, LTD.
40 HILLTOP DR.
SYOSSET,  NY  11791
Correspondent Contact RICHARD KUO
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/17/2000
Decision Date 04/27/2000
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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