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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 K913264
Device Name HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE
Applicant
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Applicant Contact MARK L FRIEDMAN
Correspondent
Mallinckrodt Group, Inc.
2111 E. Galbraith Rd.
P.O. Box 156305
Cincinnati,  OH  45215
Correspondent Contact MARK L FRIEDMAN
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received07/23/1991
Decision Date 11/01/1991
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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