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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 K884304
Device Name ORTHO PATIENT CHAIR
Applicant
Halton Furniture Mfg.
100 Elgin St. S.
Acton, Ontario
Canada L7j 2w1,  CA
Applicant Contact WAYNE NOSEWORTHY
Correspondent
Halton Furniture Mfg.
100 Elgin St. S.
Acton, Ontario
Canada L7j 2w1,  CA
Correspondent Contact WAYNE NOSEWORTHY
Regulation Number872.6250
Classification Product Code
KLC  
Date Received10/13/1988
Decision Date 04/25/1989
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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