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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 K952927
Device Name IMPACT AIR 45 4-HOLE
Applicant
Palisades Pharmaceutics, Inc.
64 N. Summit St.
Tenafly,  NJ  07670
Applicant Contact CYNTHIA ROMANOFF
Correspondent
Palisades Pharmaceutics, Inc.
64 N. Summit St.
Tenafly,  NJ  07670
Correspondent Contact CYNTHIA ROMANOFF
Regulation Number872.4200
Classification Product Code
EFB  
Date Received06/26/1995
Decision Date 08/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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