KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL

Bur, Ear, Nose And Throat

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Stammberger-sachse Intranasal-frill.

Pre-market Notification Details

Device IDK950337
510k NumberK950337
Device Name:KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
ClassificationBur, Ear, Nose And Throat
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJudith K Murphy
CorrespondentJudith K Murphy
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeEQJ  
CFR Regulation Number874.4140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-01-27
Decision Date1995-08-23

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