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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 K850036
Device Name COLTENE PRECISE
Applicant
Coltene, Inc.
C/O Robert Bauer & Associates
111 N. Wabash
Chicago,  IL  60602
Applicant Contact ROBERT W BAUER
Correspondent
Coltene, Inc.
C/O Robert Bauer & Associates
111 N. Wabash
Chicago,  IL  60602
Correspondent Contact ROBERT W BAUER
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/07/1985
Decision Date 02/08/1985
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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