REPROCESSED DISPOSABLE TROCARS

Trocar, Sinus

ADVEN MEDICAL

The following data is part of a premarket notification filed by Adven Medical with the FDA for Reprocessed Disposable Trocars.

Pre-market Notification Details

Device IDK013987
510k NumberK013987
Device Name:REPROCESSED DISPOSABLE TROCARS
ClassificationTrocar, Sinus
Applicant ADVEN MEDICAL 1001 SLATON HWY. Lubbock,  TX  79404
ContactMark W Aldana
CorrespondentMark W Aldana
ADVEN MEDICAL 1001 SLATON HWY. Lubbock,  TX  79404
Product CodeKBG  
CFR Regulation Number874.4420 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-12-04
Decision Date2002-03-01
Summary:summary

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