Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name suture, absorbable, synthetic, polyglycolic acid
510(k) Number K150717
Device Name Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron
Applicant
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
Correspondent
Regulatory Insight, Inc.
33 Golden Eagle Lane
Littleton,  CO  80127
Correspondent Contact Kevin Walls
Regulation Number878.4493
Classification Product Code
GAM  
Subsequent Product Code
NEW  
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
-
-