DURALASTIC ANATOMICAL MALAR IMPLANTS

Implant, Malar

ALLIED BIOMEDICAL CORP.

The following data is part of a premarket notification filed by Allied Biomedical Corp. with the FDA for Duralastic Anatomical Malar Implants.

Pre-market Notification Details

Device IDK971479
510k NumberK971479
Device Name:DURALASTIC ANATOMICAL MALAR IMPLANTS
ClassificationImplant, Malar
Applicant ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles,  CA  93446
ContactGerald Hanson
CorrespondentGerald Hanson
ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 Paso Robles,  CA  93446
Product CodeLZK  
CFR Regulation Number878.3550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-23
Decision Date1997-07-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
M724M741 K971479 000
M724M611 K971479 000
M724M711 K971479 000
M724M731 K971479 000
M724M311 K971479 000
M724M321 K971479 000
M724M331 K971479 000
M724M521 K971479 000
M724M531 K971479 000
M724M541 K971479 000
M724M621 K971479 000
M724M631 K971479 000
M724M721 K971479 000
M724M511 K971479 000

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