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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Generator, High-Voltage, X-Ray, Diagnostic
510(k) Number K910020
Device Name CAPINTEC THYROID UPTAKE SYSTEM-VARIOUS MODELS
Applicant
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact ANNE DELL
Correspondent
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact ANNE DELL
Regulation Number892.1700
Classification Product Code
IZO  
Date Received01/03/1991
Decision Date 04/08/1991
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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