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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 K150717
Device Name Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
M/s. Meril Endo Surgery Private Limited
Third Floor, E1-E3, Meril Park, Survey No. 135/2/B & 174/2
Muktanand Marg
Chala, Vapi,  IN
Applicant Contact Umesh Sharma
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4493
Classification Product Code
Subsequent Product Code
Date Received03/19/2015
Decision Date 10/14/2015
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