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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, Dental, With Operative Unit
510(k) Number K923461
Device Name PM2002 PROLINE, PM2002 PROLINE EC
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 Number872.6250
Classification Product Code
KLC  
Date Received07/14/1992
Decision Date 12/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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