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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 K771908
Device Name ISO-SHIELD SALIVA ABSORBERS
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number872.6050
Classification Product Code
KHR  
Date Received10/11/1977
Decision Date 11/07/1977
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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