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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name appliance, fixation, nail/blade/plate combination, multiple component
510(k) Number K190486
Device Name Pitkar External Fixation System
Applicant
S H Pitkar Orthotools Pvt Ltd.
Plot No. EL 32, J Block, MIDC Bhosari
Pune,  IN 411026
Applicant Contact Vivek Mangalwedhekar
Correspondent
S H Pitkar Orthotools Pvt Ltd.
Plot No. EL 32, J Block, MIDC Bhosari
Pune,  IN 411026
Correspondent Contact Vivek Mangalwedhekar
Regulation Number888.3030
Classification Product Code
KTT  
Subsequent Product Code
JDW  
Date Received02/28/2019
Decision Date 10/16/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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