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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K911783
Device Name ALLEGRO VIEWING WAND
Applicant
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Applicant Contact BRUCE LEGGETT
Correspondent
I.S.G. Technologies, Inc.
6509 Airport Rd.
Mississauga Ontario,  CA L4V 1S7
Correspondent Contact BRUCE LEGGETT
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received04/22/1991
Decision Date 04/07/1994
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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