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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe, Uptake, Nuclear
510(k) Number K921428
Device Name CAPTUS 500
Applicant
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact ANN DELL
Correspondent
Capintec Instruments, Inc.
540 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact ANN DELL
Regulation Number892.1320
Classification Product Code
IZD  
Date Received03/24/1992
Decision Date 05/28/1992
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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