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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name instrument, ent manual surgical
510(k) Number K172737
Device Name MESIRE - Balloon Sinus Dilatation System
Applicant
M/s. Meril Life Sciences Private Limited
Survey No. 135/139, Bilakhia House, Muktanand Marg
Chala, Vapi,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
M/s. Meril Life Sciences Private Limited
Survey No. 135/139, Bilakhia House, Muktanand Marg
Chala, Vapi,  IN 396191
Correspondent Contact Umesh Sharma
Regulation Number874.4420
Classification Product Code
LRC  
Date Received09/11/2017
Decision Date 12/12/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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