TITANIUM HEMOSTATIC CLIP

Clip, Hemostatic

EISNER USA, INC.

The following data is part of a premarket notification filed by Eisner Usa, Inc. with the FDA for Titanium Hemostatic Clip.

Pre-market Notification Details

Device IDK972745
510k NumberK972745
Device Name:TITANIUM HEMOSTATIC CLIP
ClassificationClip, Hemostatic
Applicant EISNER USA, INC. 15 CASWELL LANE, BOATYARD SQ. Plymouth,  MA  02360
ContactEllen Henve-unepp
CorrespondentEllen Henve-unepp
EISNER USA, INC. 15 CASWELL LANE, BOATYARD SQ. Plymouth,  MA  02360
Product CodeMCH  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-23
Decision Date1997-10-21
Summary:summary

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