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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomographic
510(k) Number K973864
Device Name COMBI ELEVATOR-2 & COMBI ELEVATOR-2 TOMO
Applicant
Pausch Corp.
808 Shrewsbury Ave.
Tenton Falls,  NJ  07724
Applicant Contact KENNETH J H. RICE
Correspondent
Pausch Corp.
808 Shrewsbury Ave.
Tenton Falls,  NJ  07724
Correspondent Contact KENNETH J H. RICE
Regulation Number892.1740
Classification Product Code
IZF  
Subsequent Product Codes
IYB   IZZ  
Date Received10/09/1997
Decision Date 06/17/1998
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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