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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name camera, scintillation (gamma)
510(k) Number K761159
Device Name PORTACAMERA 11-B
Applicant
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENERAL ELECTRIC CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number892.1100
Classification Product Code
IYX  
Date Received11/29/1976
Decision Date 12/06/1976
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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