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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name staple, implantable
510(k) Number K200320
Device Name Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload
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 396191
Applicant Contact Umesh Sharma
Correspondent
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 396191
Correspondent Contact Umesh Sharma
Regulation Number878.4750
Classification Product Code
GDW  
Date Received02/07/2020
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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