TLS SURGICAL MARKER

Marker, Skin

POREX MEDICAL

The following data is part of a premarket notification filed by Porex Medical with the FDA for Tls Surgical Marker.

Pre-market Notification Details

Device IDK831372
510k NumberK831372
Device Name:TLS SURGICAL MARKER
ClassificationMarker, Skin
Applicant POREX MEDICAL 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFZZ  
CFR Regulation Number878.4660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-04-27
Decision Date1983-06-24

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