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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, polypropylene
510(k) Number K000537
Device Name POLYPROPYLENE 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 Number878.5010
Classification Product Code
GAW  
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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