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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 K880474
Device Name AREA (DENTAL CHAIR)
Applicant
Alpine Dental Equipment Co.
325 Elmwood Ave.
East Orange,  NJ  07018
Applicant Contact NORMAN SMITH
Correspondent
Alpine Dental Equipment Co.
325 Elmwood Ave.
East Orange,  NJ  07018
Correspondent Contact NORMAN SMITH
Regulation Number872.6250
Classification Product Code
KLC  
Date Received02/04/1988
Decision Date 09/23/1988
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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