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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Digital Image Storage, Radiological
510(k) Number K950279
Device Name TOMTECP90
Applicant
Tomtec Imaging Systems, Inc.
4775 Walnut St., Suite C
Boulder,  CO  80301
Applicant Contact LISA CASSIDY
Correspondent
Tomtec Imaging Systems, Inc.
4775 Walnut St., Suite C
Boulder,  CO  80301
Correspondent Contact LISA CASSIDY
Regulation Number892.2010
Classification Product Code
LMB  
Date Received01/24/1995
Decision Date 09/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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