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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Processor, Radiographic-Film, Automatic
510(k) Number K991435
Device Name AII-PRO 100 PLUS AND ALL-PRO 200
Applicant
All-Pro Imaging Corp.
70 Cantiague Rock Rd.
P.O. Box 870
Hicksville,  NY  11801
Applicant Contact FREDERICK R FISCHER
Correspondent
All-Pro Imaging Corp.
70 Cantiague Rock Rd.
P.O. Box 870
Hicksville,  NY  11801
Correspondent Contact FREDERICK R FISCHER
Regulation Number892.1900
Classification Product Code
IXW  
Date Received04/26/1999
Decision Date 05/20/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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