KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME

Laparoscope, General & Plastic Surgery

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 Pediatric Pyloric Spreader, Pylorotome, Endotome.

Pre-market Notification Details

Device IDK951252
510k NumberK951252
Device Name:KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME
ClassificationLaparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
ContactJudith K Murphy
CorrespondentJudith K Murphy
KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City,  CA  90230 -7600
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-20
Decision Date1995-04-25

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