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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Operative Dental
510(k) Number K883775
Device Name PORTABLE II DENTAL DELIVERY SYSTEM
Applicant
Dntl Corp.
6726 S. Revere Pkwy.
Englewood,  CO  80112
Applicant Contact JOHN W MCPEEK
Correspondent
Dntl Corp.
6726 S. Revere Pkwy.
Englewood,  CO  80112
Correspondent Contact JOHN W MCPEEK
Regulation Number872.6640
Classification Product Code
EIA  
Date Received09/06/1988
Decision Date 10/14/1988
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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