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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 K923334
Device Name MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER
Applicant
Cook, Inc.
111 Sandiford Dr.
Stouffville
Ontario L4a 7x5,  CA
Applicant Contact CARL D DICKIE
Correspondent
Cook, Inc.
111 Sandiford Dr.
Stouffville
Ontario L4a 7x5,  CA
Correspondent Contact CARL D DICKIE
Regulation Number892.1850
Classification Product Code
IXA  
Date Received07/07/1992
Decision Date 01/26/1993
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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