EPTFE-Coated Auricular Implant

Prosthesis, Ear, Internal

Implantech Associates Inc.

The following data is part of a premarket notification filed by Implantech Associates Inc. with the FDA for Eptfe-coated Auricular Implant.

Pre-market Notification Details

Device IDK172389
510k NumberK172389
Device Name:EPTFE-Coated Auricular Implant
ClassificationProsthesis, Ear, Internal
Applicant Implantech Associates Inc. 6025 Nicolle St., Suite B Ventura,  CA  93003
ContactCraig Arthur
CorrespondentAllison Komiyama
AcKnowledge Regulatory Strategies, LLC 2834 Hawthorn St. San Diego,  CA  92104
Product CodeFZD  
Subsequent Product CodeFWP
Subsequent Product CodeFZE
Subsequent Product CodeLZK
CFR Regulation Number878.3590 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-08-08
Decision Date2018-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724EPTFEAPB63R1 K172389 000
M724EPTFEABF58L1 K172389 000
M724EPTFEABF55R1 K172389 000
M724EPTFEABF55L1 K172389 000
M724EPTFEAAH63R1 K172389 000
M724EPTFEAAH63L1 K172389 000
M724EPTFEAAH61R1 K172389 000
M724EPTFEAAH61L1 K172389 000
M724EPTFEAAH58R1 K172389 000
M724EPTFEAAH58L1 K172389 000
M724EPTFEAAH55R1 K172389 000
M724EPTFEABF58R1 K172389 000
M724EPTFEABF61L1 K172389 000
M724EPTFEAPB63L1 K172389 000
M724EPTFEAPB61R1 K172389 000
M724EPTFEAPB61L1 K172389 000
M724EPTFEAPB58R1 K172389 000
M724EPTFEAPB58L1 K172389 000
M724EPTFEAPB55R1 K172389 000
M724EPTFEAPB55L1 K172389 000
M724EPTFEABF63R1 K172389 000
M724EPTFEABF63L1 K172389 000
M724EPTFEABF61R1 K172389 000
M724EPTFEAAH55L1 K172389 000

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