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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 K880068
Device Name EFFERVESCENT DENTURE CLEANSER
Applicant
Perrigo Co.
117 Water St.
Allegan,  MI  49010
Applicant Contact RICK LEBER
Correspondent
Perrigo Co.
117 Water St.
Allegan,  MI  49010
Correspondent Contact RICK LEBER
Regulation Number872.3520
Classification Product Code
EFT  
Date Received01/11/1988
Decision Date 03/07/1988
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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