TISSURE RETRACTORS

Retractor

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Tissure Retractors.

Pre-market Notification Details

Device IDK791122
510k NumberK791122
Device Name:TISSURE RETRACTORS
ClassificationRetractor
Applicant XOMED, INC. 1318 LONEDELL RD. Arnold,  MO  63010
Product CodeGAD  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-06-15
Decision Date1979-07-10

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