ZIPKNOT, MODEL 1017-3000

Clip, Implantable

MEDICINELODGE, INC.

The following data is part of a premarket notification filed by Medicinelodge, Inc. with the FDA for Zipknot, Model 1017-3000.

Pre-market Notification Details

Device IDK072525
510k NumberK072525
Device Name:ZIPKNOT, MODEL 1017-3000
ClassificationClip, Implantable
Applicant MEDICINELODGE, INC. 180 SOUTH 600 WEST Logan,  UT  84321
ContactMary Sinnott
CorrespondentMary Sinnott
MEDICINELODGE, INC. 180 SOUTH 600 WEST Logan,  UT  84321
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-07
Decision Date2007-10-05

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