KARL STORZ LARYNGOSCOPE ACCESSORIES

Circuit, Breathing (w Connector, Adaptor, Y Piece)

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 Laryngoscope Accessories.

Pre-market Notification Details

Device IDK944295
510k NumberK944295
Device Name:KARL STORZ LARYNGOSCOPE ACCESSORIES
ClassificationCircuit, Breathing (w Connector, Adaptor, Y Piece)
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 CodeCAI  
CFR Regulation Number868.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-29
Decision Date1994-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04048551104323 K944295 000

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