KARL STORZ INSULATED SCISSORS

Coagulator-cutter, Endoscopic, Unipolar (and Accessories)

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 Insulated Scissors.

Pre-market Notification Details

Device IDK944297
510k NumberK944297
Device Name:KARL STORZ INSULATED SCISSORS
ClassificationCoagulator-cutter, Endoscopic, Unipolar (and Accessories)
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactBetty Johnson
CorrespondentBetty Johnson
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeKNF  
CFR Regulation Number884.4160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-09-06
Decision Date1994-12-15

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