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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 K083739
Device Name HYDRORISE AND HYDROSYSTEM
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 Received12/16/2008
Decision Date 03/26/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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