ENDO-SCRUB/ENDO-SCRUB 2

Nasopharyngoscope (flexible Or Rigid)

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Endo-scrub/endo-scrub 2.

Pre-market Notification Details

Device IDK982594
510k NumberK982594
Device Name:ENDO-SCRUB/ENDO-SCRUB 2
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
ContactDebra B Cortner
CorrespondentDebra B Cortner
XOMED, INC. 6743 SOUTHPOINT DR. NORTH Jacksonville,  FL  32216 -0980
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-07-24
Decision Date1998-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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20681490050986 K982594 000
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20643169437252 K982594 000
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00643169360884 K982594 000
20681490697785 K982594 000
20681490697761 K982594 000
20681490697754 K982594 000
20681490050849 K982594 000

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