AIGIS RX R PM/ AIGIS RX R ICD

Mesh, Surgical, Polymeric

TYRX , INC.

The following data is part of a premarket notification filed by Tyrx , Inc. with the FDA for Aigis Rx R Pm/ Aigis Rx R Icd.

Pre-market Notification Details

Device IDK130943
510k NumberK130943
Device Name:AIGIS RX R PM/ AIGIS RX R ICD
ClassificationMesh, Surgical, Polymeric
Applicant TYRX , INC. 1 DEER PARK DR. SUITE G Monmouth Junction,  NJ  08852
ContactSusan Olinger
CorrespondentSusan Olinger
TYRX , INC. 1 DEER PARK DR. SUITE G Monmouth Junction,  NJ  08852
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2013-04-04
Decision Date2013-05-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00643169935907 K130943 000
00643169935891 K130943 000
00643169468856 K130943 000
00643169468795 K130943 000

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