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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cassette, Radiographic Film
510(k) Number K935397
Device Name NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS
Applicant
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Applicant Contact CHRISTINE L JESS
Correspondent
Victoreen, Inc.
6000 Cochran Rd.
Cleveland,  OH  44130
Correspondent Contact CHRISTINE L JESS
Regulation Number892.1850
Classification Product Code
IXA  
Date Received11/09/1993
Decision Date 12/15/1993
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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