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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(k) Number K160771
Device Name Destiknee Total Knee System
Applicant
Meril Healthcare Private Limited
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Applicant Contact Umesh Sharma
Correspondent
Ajw Technology Consultants, Inc.
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact Jon Ward
Regulation Number888.3560
Classification Product Code
JWH  
Date Received03/21/2016
Decision Date 12/19/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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