DUOCLIPPER TITANIUM CLIPS

Clip, Implantable

SCION INTERNATIONAL, INC.

The following data is part of a premarket notification filed by Scion International, Inc. with the FDA for Duoclipper Titanium Clips.

Pre-market Notification Details

Device IDK973652
510k NumberK973652
Device Name:DUOCLIPPER TITANIUM CLIPS
ClassificationClip, Implantable
Applicant SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
ContactStephen Chakoff
CorrespondentStephen Chakoff
SCION INTERNATIONAL, INC. 5200 BLUE LAGOON DRIVE, SUITE 890 Miami,  FL  33126
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-09-25
Decision Date1998-03-27

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