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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K870856
Device Name COSMOS
Applicant
Pausch Corp.
96 Birch Ave.
Little Silver,  NJ  07739
Applicant Contact J. H TICE
Correspondent
Pausch Corp.
96 Birch Ave.
Little Silver,  NJ  07739
Correspondent Contact J. H TICE
Regulation Number892.1770
Classification Product Code
IYB  
Date Received03/03/1987
Decision Date 03/30/1987
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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