KSEA BIPOLAR GOAGULATING FORCEPS

Nasopharyngoscope (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 Ksea Bipolar Goagulating Forceps.

Pre-market Notification Details

Device IDK962396
510k NumberK962396
Device Name:KSEA BIPOLAR GOAGULATING FORCEPS
ClassificationNasopharyngoscope (flexible Or Rigid)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin A Kennan
CorrespondentKevin A Kennan
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeEOB  
CFR Regulation Number874.4760 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-21
Decision Date1996-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551348895 K962396 000
04048551404515 K962396 000
04048551404508 K962396 000
04048551251942 K962396 000
04048551170267 K962396 000
04048551170250 K962396 000

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