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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Cine Film
510(k) Number K850421
Device Name CINE RADIOGRAPHIC FILM PROCESSOR M-45CR
Applicant
The Allen Products Co.
180 Wampus Ln.
Milford,  CT  06460
Applicant Contact ROBERT N STILES
Correspondent
The Allen Products Co.
180 Wampus Ln.
Milford,  CT  06460
Correspondent Contact ROBERT N STILES
Regulation Number892.1900
Classification Product Code
IXX  
Date Received02/04/1985
Decision Date 03/22/1985
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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