HG II FIXTURE SYSTEM

Implant, Endosseous, Root-form

HIOSSEN INC.

The following data is part of a premarket notification filed by Hiossen Inc. with the FDA for Hg Ii Fixture System.

Pre-market Notification Details

Device IDK090237
510k NumberK090237
Device Name:HG II FIXTURE SYSTEM
ClassificationImplant, Endosseous, Root-form
Applicant HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills,  PA  19030
ContactMinjoo Kim
CorrespondentMinjoo Kim
HIOSSEN INC. 85 BEN FAIRLESS DRIVE Fairless Hills,  PA  19030
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-02-02
Decision Date2009-04-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00814913021416 K090237 000
00814913021287 K090237 000
00814913021270 K090237 000
00814913021263 K090237 000
00814913021256 K090237 000
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00814913021232 K090237 000
00814913021225 K090237 000
00814913021218 K090237 000
00814913021201 K090237 000
00814913021294 K090237 000
00814913021300 K090237 000
00814913021317 K090237 000
00814913021409 K090237 000
00814913021393 K090237 000
00814913021386 K090237 000
00814913021379 K090237 000
00814913021362 K090237 000
00814913021355 K090237 000
00814913021348 K090237 000
00814913021331 K090237 000
00814913021324 K090237 000
00814913021195 K090237 000

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