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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 K172936
Device Name Destiknee™ Total Knee System
Applicant
Meril Healthcare Pvt. , Ltd.
Survey # 135/2/B & 174/2, H1-H3 , Meril Park,
Muktanand Marg, Chala
Vapi,  IN 396191
Applicant Contact Bhavik Gondaliya
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Regulation Number888.3560
Classification Product Code
JWH  
Date Received09/26/2017
Decision Date 11/30/2017
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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