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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 K954165
Device Name PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM
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 Received09/05/1995
Decision Date 12/05/1995
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
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