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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K955750
Device Name TELETOM
Applicant
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Applicant Contact WOLFRAM K HILL
Correspondent
Berchtold Holding GmbH
Ludwigstaler St. 25
Tuttlingen,  DE D-78532
Correspondent Contact WOLFRAM K HILL
Regulation Number878.4960
Classification Product Code
FQO  
Subsequent Product Code
GDC  
Date Received12/18/1995
Decision Date 02/08/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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