Pitch-Patchs

Mesh, Surgical, Polymeric

Xiros Ltd

The following data is part of a premarket notification filed by Xiros Ltd with the FDA for Pitch-patchs.

Pre-market Notification Details

Device IDK211563
510k NumberK211563
Device Name:Pitch-Patchs
ClassificationMesh, Surgical, Polymeric
Applicant Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds,  GB Ls17 7ue
ContactSteve Curran
CorrespondentSteve Curran
Xiros Ltd Springfield House Lane, Whitehouse Lane Leeds,  GB Ls17 7ue
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-20
Decision Date2021-08-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060267132024 K211563 000
05060267132017 K211563 000

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