DCI ENDOSCOPE

Laparoscope, General & Plastic Surgery

KARL STORZ ENDOSCOPY

The following data is part of a premarket notification filed by Karl Storz Endoscopy with the FDA for Dci Endoscope.

Pre-market Notification Details

Device IDK991171
510k NumberK991171
Device Name:DCI ENDOSCOPE
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactKevin A Kennan
CorrespondentKevin A Kennan
KARL STORZ ENDOSCOPY 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-04-07
Decision Date1999-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551324707 K991171 000
04048551049556 K991171 000

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