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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 K954222
Device Name VIDEO ENHANCEMENT UNIT
Applicant
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Applicant Contact JAMES C FURSE
Correspondent
Perkins Mfg. Co.
1510 N.Washington Ave.
Dallas,  TX  75204
Correspondent Contact JAMES C FURSE
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/11/1995
Decision Date 12/08/1995
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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