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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, X-Ray, Extraoral With Timer
510(k) Number K970263
Device Name PM 2002 CC PROLINE
Applicant
Planmeca Oy
Asentajankatu 6
Helsinki,  FI 00880
Applicant Contact LARS MORING
Correspondent
Planmeca Oy
Asentajankatu 6
Helsinki,  FI 00880
Correspondent Contact LARS MORING
Regulation Number872.1800
Classification Product Code
EHD  
Date Received01/23/1997
Decision Date 02/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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