DORSAL NAIL PLATE, ANATOMICAL

Plate, Fixation, Bone

HAND INNOVATIONS, LLC.

The following data is part of a premarket notification filed by Hand Innovations, Llc. with the FDA for Dorsal Nail Plate, Anatomical.

Pre-market Notification Details

Device IDK052248
510k NumberK052248
Device Name:DORSAL NAIL PLATE, ANATOMICAL
ClassificationPlate, Fixation, Bone
Applicant HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami,  FL  33176
ContactErnesto Hernandez
CorrespondentErnesto Hernandez
HAND INNOVATIONS, LLC. 8905 SW 87TH AVENUE SUITE 220 Miami,  FL  33176
Product CodeHRS  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-18
Decision Date2005-09-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00880304535268 K052248 000
00887868072796 K052248 000
00887868072772 K052248 000
00887868070747 K052248 000
00887868070723 K052248 000
00887868546044 K052248 000
00887868546020 K052248 000

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