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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name suture, nonabsorbable, synthetic, polyethylene
510(k) Number K162247
Device Name PERMATAPE
Applicant
MEDOS INTERNATIONAL SARL
CHEMIN-BLANC 38
LE LOCLE NEUCHATEL,  CH 2400
Applicant Contact TATYANA KORSUNSKY
Correspondent
DEPUY MITEK, A JOHNSON AND JOHNSON COMPANY
325 PARAMOUNT DRIVE
RAYNHAM,  MA  02767
Correspondent Contact TATYANA KORSUNSKY
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/10/2016
Decision Date 12/15/2016
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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