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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 K970812
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 Received03/05/1997
Decision Date 08/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
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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