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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 K893890
Device Name FD4500 (DENTAL CHAIR)
Applicant
Oriola OY Finndent
Sf-07230 Monninkyla
Finland,  FI
Applicant Contact JOHN HOGAN
Correspondent
Oriola OY Finndent
Sf-07230 Monninkyla
Finland,  FI
Correspondent Contact JOHN HOGAN
Regulation Number872.6250
Classification Product Code
KLC  
Date Received05/30/1989
Decision Date 08/15/1989
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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