KARL STORZ BOUGIES, SOUNDS, DILATORS

Esophagoscope (flexible Or Rigid)

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 Bougies, Sounds, Dilators.

Pre-market Notification Details

Device IDK946331
510k NumberK946331
Device Name:KARL STORZ BOUGIES, SOUNDS, DILATORS
ClassificationEsophagoscope (flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty M Johnson
CorrespondentBetty M Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeEOX  
CFR Regulation Number874.4710 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-29
Decision Date1995-03-02

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