ZIMMON PAPILLOTOME

Unit, Electrosurgical, Endoscopic (with Or Without Accessories)

WILSON-COOK MEDICAL, INC.

The following data is part of a premarket notification filed by Wilson-cook Medical, Inc. with the FDA for Zimmon Papillotome.

Pre-market Notification Details

Device IDK901443
510k NumberK901443
Device Name:ZIMMON PAPILLOTOME
ClassificationUnit, Electrosurgical, Endoscopic (with Or Without Accessories)
Applicant WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
ContactRichard F Marshall
CorrespondentRichard F Marshall
WILSON-COOK MEDICAL, INC. 4900 BETHANIA STATION RD. & 5951 GRASSY CREEK BLVD. Winston-salem,  NC  27105
Product CodeKNS  
CFR Regulation Number876.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-03-27
Decision Date1990-06-18

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