GYNEX EXTENDED REACH NEEDLE

Set, Anesthesia, Paracervical

GYNEX CORP.

The following data is part of a premarket notification filed by Gynex Corp. with the FDA for Gynex Extended Reach Needle.

Pre-market Notification Details

Device IDK980238
510k NumberK980238
Device Name:GYNEX EXTENDED REACH NEEDLE
ClassificationSet, Anesthesia, Paracervical
Applicant GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
ContactDavid W Schlerf
CorrespondentDavid W Schlerf
GYNEX CORP. 1000 BURNETT AVE. SUITE 450 Concord,  CA  94520
Product CodeHEE  
CFR Regulation Number884.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-23
Decision Date1998-08-21
Summary:summary

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