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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K140039
Device Name POLYCRYL
Applicant
AUROLAB
NO 1, SIVAGANGAI MAIN ROAD
VEERAPANJAN
MADURAI, TAMILNADU,  IN 625020
Applicant Contact KRISHNA KUMAR.R
Correspondent
AUROLAB
NO 1, SIVAGANGAI MAIN ROAD
VEERAPANJAN
MADURAI, TAMILNADU,  IN 625020
Correspondent Contact KRISHNA KUMAR.R
Regulation Number878.4493
Classification Product Code
GAM  
Date Received01/07/2014
Decision Date 09/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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