ENDOSCOPE SHEATH

Nasopharyngoscope (flexible Or Rigid)

XOMED-TREACE, INC.

The following data is part of a premarket notification filed by Xomed-treace, Inc. with the FDA for Endoscope Sheath.

Pre-market Notification Details

Device IDK940028
510k NumberK940028
Device Name:ENDOSCOPE SHEATH
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216 -0980
ContactArthur A Gertzman
CorrespondentArthur A Gertzman
XOMED-TREACE, INC. 6743 SOUTHPOINT DRIVE NORTH Jacksonville,  FL  32216 -0980
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-03
Decision Date1995-03-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00885074060316 K940028 000

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