KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE

Laryngoscope, 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 Subglottiscope, Neonate And Infant, Fiber Optic Light Carrier, Suction Tube.

Pre-market Notification Details

Device IDK951804
510k NumberK951804
Device Name:KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE
ClassificationLaryngoscope, Rigid
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactMarika Anderson
CorrespondentMarika Anderson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeCCW  
CFR Regulation Number868.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-19
Decision Date1995-06-05

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