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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accelerator, Linear, Medical
510(k) Number K951764
Device Name UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR
Applicant
Ptw-New York Corp.
2437 Grand Ave.
Bellmore,  NY  11710
Applicant Contact STEPHEN R SZEGLIN
Correspondent
Ptw-New York Corp.
2437 Grand Ave.
Bellmore,  NY  11710
Correspondent Contact STEPHEN R SZEGLIN
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/17/1995
Decision Date 10/07/1995
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
Recalls CDRH Recalls
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