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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorber, Saliva, Paper
510(k) Number K870383
Device Name ALGINATE WOOL FIBER
Applicant
Adri
P.O. Box 134
Park Forest,  IL  60466
Applicant Contact GEORGE H SCHERR
Correspondent
Adri
P.O. Box 134
Park Forest,  IL  60466
Correspondent Contact GEORGE H SCHERR
Regulation Number872.6050
Classification Product Code
KHR  
Date Received01/30/1987
Decision Date 04/30/1987
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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