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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K882800
Device Name COLTENE PRESIDENT JET REGULAR BODY
Applicant
Coltene, Inc.
5205 Avenida Enclinas
Carlsbao,  CA  92008
Applicant Contact JAMES K SHUCK
Correspondent
Coltene, Inc.
5205 Avenida Enclinas
Carlsbao,  CA  92008
Correspondent Contact JAMES K SHUCK
Regulation Number872.3660
Classification Product Code
ELW  
Date Received07/07/1988
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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