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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Film, Radiographic
510(k) Number K860797
Device Name MEDICAL X-RAY FILM
Applicant
India-America Trading Co.
1807 Wilshire Blvd., Suite B
Santa Monica,  CA  90403
Applicant Contact HAL NEIMAN
Correspondent
India-America Trading Co.
1807 Wilshire Blvd., Suite B
Santa Monica,  CA  90403
Correspondent Contact HAL NEIMAN
Regulation Number892.1840
Classification Product Code
IWZ  
Date Received03/04/1986
Decision Date 03/13/1986
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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