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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Teeth, Porcelain
510(k) Number K932012
Device Name CAPS
Applicant
Chemichl, Inc.
17410 NE 195th St.
Woodinville,  WA  98072
Applicant Contact DANIEL H JONSON
Correspondent
Chemichl, Inc.
17410 NE 195th St.
Woodinville,  WA  98072
Correspondent Contact DANIEL H JONSON
Regulation Number872.3920
Classification Product Code
ELL  
Date Received04/23/1993
Decision Date 11/03/1993
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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