HYDROGUM 5

Material, Impression

ZHERMACK S.P.A.

The following data is part of a premarket notification filed by Zhermack S.p.a. with the FDA for Hydrogum 5.

Pre-market Notification Details

Device IDK051424
510k NumberK051424
Device Name:HYDROGUM 5
ClassificationMaterial, Impression
Applicant ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend,  OR  97702
ContactGerald W Shipps
CorrespondentGerald W Shipps
ZHERMACK S.P.A. 19379 BLUE LAKE LOOP Bend,  OR  97702
Product CodeELW  
CFR Regulation Number872.3660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-01
Decision Date2005-07-15

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