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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 K885054
Device Name SYSTEM SEVENTY SEVEN
Applicant
Scinticor, Inc.
9051 W. Heather Ave.
Milwaukee,  WI  53224
Applicant Contact FRANCIS R CROTEAU
Correspondent
Scinticor, Inc.
9051 W. Heather Ave.
Milwaukee,  WI  53224
Correspondent Contact FRANCIS R CROTEAU
Regulation Number892.1100
Classification Product Code
IYX  
Date Received12/07/1988
Decision Date 04/19/1989
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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