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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Optical Coherence Tomography (Oct)
510(k) Number K102599
Device Name TOMOPHASE OCTIS
Applicant
TOMOPHASE CORPORATION
14 BURGUNDY DRIVE
HAMPTON,  NH  03842
Applicant Contact DEREK BEAUPRE
Correspondent
TOMOPHASE CORPORATION
14 BURGUNDY DRIVE
HAMPTON,  NH  03842
Correspondent Contact DEREK BEAUPRE
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received09/10/2010
Decision Date 12/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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