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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 K000163
Device Name PM 2002 PROLINE/AEC
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 Received01/19/2000
Decision Date 04/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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