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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 K043118
Device Name HYDROGUM SOFT
Applicant
ZHERMACK S.P.A.
19379 BLUE LAKE LOOP
BEND,  OR  97702
Applicant Contact GERALD W SHIPPS
Correspondent
ZHERMACK S.P.A.
19379 BLUE LAKE LOOP
BEND,  OR  97702
Correspondent Contact GERALD W SHIPPS
Regulation Number872.3660
Classification Product Code
ELW  
Date Received11/10/2004
Decision Date 01/24/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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