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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K984013
Device Name PLANMECA INTRACAM STATION
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 Number872.6640
Classification Product Code
EIA  
Date Received11/11/1998
Decision Date 01/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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