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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 K952778
Device Name CHESHIRE
Applicant
Perceptive Systems, Inc.
1919 14th St., Suite 405
Boulder,  CO  80302
Applicant Contact HOWARD FOSTER
Correspondent
Perceptive Systems, Inc.
1919 14th St., Suite 405
Boulder,  CO  80302
Correspondent Contact HOWARD FOSTER
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received06/16/1995
Decision Date 09/06/1995
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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