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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, X-Ray, Fluorographic, Cine Or Spot
510(k) Number K881688
Device Name DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact GARY L PEMBROKE
Correspondent
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Correspondent Contact GARY L PEMBROKE
Regulation Number892.1620
Classification Product Code
IZJ  
Date Received04/19/1988
Decision Date 05/18/1988
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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