IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)

Implant, Malar

IMPLANTECH ASSOCIATES, INC.

The following data is part of a premarket notification filed by Implantech Associates, Inc. with the FDA for Implantech Composite Facial Implants (malar, Chin, And Nasal).

Pre-market Notification Details

Device IDK002886
510k NumberK002886
Device Name:IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL)
ClassificationImplant, Malar
Applicant IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura,  CA  93003
ContactEdward Leicht
CorrespondentEdward Leicht
IMPLANTECH ASSOCIATES, INC. 2064 EASTMAN AVE., UNIT 101 Ventura,  CA  93003
Product CodeLZK  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-09-15
Decision Date2000-11-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724EPTFEVSDCW55451 K002886 000
M724EPTFECSCM1 K002886 000
M724EPTFECSCL1 K002886 000
M724EPTFEBSMIIXL1 K002886 000
M724EPTFEBSMIIS1 K002886 000
M724EPTFEBSMIIM1 K002886 000
M724EPTFEBSMIIL1 K002886 000
M724EPTFEACXL1 K002886 000
M724EPTFEACS1 K002886 000
M724EPTFEACM1 K002886 000
M724EPTFEACL1 K002886 000
M724EPTFEVSDCN47301 K002886 000
M724EPTFEVSDC0031 K002886 000
M724EPTFEVSDC0011 K002886 000
M724EPTFETMSXL1 K002886 000
M724EPTFEFDI251 K002886 000
M724EPTFEEACXL1 K002886 000
M724EPTFEEACS1 K002886 000
M724EPTFECSCS1 K002886 000
M724EPTFECSCXL1 K002886 000
M724EPTFEVSDCW50501 K002886 000
M724EPTFEVSDCW50351 K002886 000
M724EPTFEVSDCW50301 K002886 000
M724EPTFEVSDCW50201 K002886 000
M724EPTFEVSDCN47501 K002886 000
M724EPTFEVSDCN47401 K002886 000
M724EPTFEVSDC0101 K002886 000
M724EPTFEVSDC0041 K002886 000
M724EPTFEVSDC0021 K002886 000
M724EPTFETMSS1 K002886 000
M724EPTFETMSM1 K002886 000
M724EPTFETMSL1 K002886 000
M724EPTFEFDI451 K002886 000
M724EPTFEFDI351 K002886 000
M724EPTFEFDI151 K002886 000
M724EPTFEEACM1 K002886 000
M724EPTFEEACL1 K002886 000
M724EPTFECSCXS1 K002886 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.