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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K875106
Device Name PB-A LEAD-ACID BATTERY CONVERSION KIT
Applicant
Diagnostic Imaging Specialists Corp.
163 St. Malo St.
St. Malo, Manitoba,  CA R0A1T0
Applicant Contact GELSKEY, PH.D.
Correspondent
Diagnostic Imaging Specialists Corp.
163 St. Malo St.
St. Malo, Manitoba,  CA R0A1T0
Correspondent Contact GELSKEY, PH.D.
Regulation Number892.1720
Classification Product Code
IZL  
Date Received12/14/1987
Decision Date 02/22/1988
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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