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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cleanser, Denture, Over The Counter
510(k) Number K890668
Device Name CLEAN DENT
Applicant
Lincoln Park Dental Laboratory
1500 Loucks Rd.
York,  PA  17404
Applicant Contact ALBERT G MUNCHEL
Correspondent
Lincoln Park Dental Laboratory
1500 Loucks Rd.
York,  PA  17404
Correspondent Contact ALBERT G MUNCHEL
Regulation Number872.3520
Classification Product Code
EFT  
Date Received02/09/1989
Decision Date 04/17/1989
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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