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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K854645
Device Name GOLD AIR, GOLD LIGHT
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 Number872.4200
Classification Product Code
EFB  
Date Received11/19/1985
Decision Date 03/12/1986
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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