Precision S 4K Sinuscope

Nasopharyngoscope (flexible Or Rigid)

Stryker

The following data is part of a premarket notification filed by Stryker with the FDA for Precision S 4k Sinuscope.

Pre-market Notification Details

Device IDK191102
510k NumberK191102
Device Name:Precision S 4K Sinuscope
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant Stryker 5900 Optical Court San Jose,  CA  95138
ContactJessie Duong
CorrespondentJessie Duong
Stryker 5900 Optical Court San Jose,  CA  95138
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-25
Decision Date2019-09-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327412192 K191102 000
07613327412086 K191102 000
07613327412079 K191102 000
07613327412062 K191102 000
07613327412055 K191102 000
07613327412048 K191102 000
07613327412031 K191102 000
07613327412024 K191102 000
07613327412017 K191102 000
07613327412093 K191102 000
07613327412109 K191102 000
07613327412185 K191102 000
07613327412178 K191102 000
07613327412161 K191102 000
07613327412154 K191102 000
07613327412147 K191102 000
07613327412130 K191102 000
07613327412123 K191102 000
07613327412116 K191102 000
07613327412000 K191102 000

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