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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Impression
510(k) Number K890449
Device Name PERMAGUM PUTTY SOFT & PERMAGUM GARRANT
Applicant
Wacker-Chemie GmbH
Prinzregentenstrabe 22
D-8000 Munchen 22
East Germany,  MY
Applicant Contact DR. P KOCHS
Correspondent
Wacker-Chemie GmbH
Prinzregentenstrabe 22
D-8000 Munchen 22
East Germany,  MY
Correspondent Contact DR. P KOCHS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received01/27/1989
Decision Date 07/27/1989
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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