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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Therapeutic, X-Ray
510(k) Number K971074
Device Name THERAPAX SXT 150
Applicant
Pantak, Inc.
31 Business Park Dr.
Branford,  CT  06405
Applicant Contact GREG MOREAU
Correspondent
Pantak, Inc.
31 Business Park Dr.
Branford,  CT  06405
Correspondent Contact GREG MOREAU
Regulation Number892.5900
Classification Product Code
JAD  
Date Received03/24/1997
Decision Date 06/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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