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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cleaner, Denture, Mechanical
510(k) Number K883403
Device Name DENTA PLUS
Applicant
Connoisseurs Products Corp.
100 Fellsway W.
Somerville,  MA  02145
Applicant Contact KARL KALTENBACH
Correspondent
Connoisseurs Products Corp.
100 Fellsway W.
Somerville,  MA  02145
Correspondent Contact KARL KALTENBACH
Regulation Number872.3530
Classification Product Code
JER  
Date Received08/11/1988
Decision Date 10/25/1988
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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