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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 K160240
Device Name Perimeter Otis™ 1.0 Optical Coherence Tomography System
Applicant
Perimeter Medical Imaging, Inc.
156 Front St. W., Suite 501
Toronto,  CA M5J 2L6
Applicant Contact ELIZABETH MUNRO
Correspondent
Perimeter Medical Imaging, Inc.
156 Front St. W., Suite 501
Toronto,  CA M5J 2L6
Correspondent Contact ELIZABETH MUNRO
Regulation Number892.1560
Classification Product Code
NQQ  
Date Received02/01/2016
Decision Date 05/13/2016
Decision SE - With Limitations (SESU)
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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