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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K102556
Device Name VOLPARA, VERSION 1.3
Applicant
Matakina Technology Limited
Level 6,
86 Victoria St.
Wellington,  NZ 6142
Applicant Contact SHEILA W PICKERING
Correspondent
Matakina Technology Limited
Level 6,
86 Victoria St.
Wellington,  NZ 6142
Correspondent Contact SHEILA W PICKERING
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/07/2010
Decision Date 10/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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