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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, Film Marking, Radiographic
510(k) Number K923533
Device Name ADMARK
Applicant
Planmeca USA, Inc.
Asentajasnkatu 6
00810 Helsinki
Finland,  FI
Applicant Contact ISMO SEPPA
Correspondent
Planmeca USA, Inc.
Asentajasnkatu 6
00810 Helsinki
Finland,  FI
Correspondent Contact ISMO SEPPA
Regulation Number892.1640
Classification Product Code
JAC  
Date Received07/16/1992
Decision Date 03/04/1993
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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