HEMO-O-LOK

Clip, Implantable

KING & SPALDING

The following data is part of a premarket notification filed by King & Spalding with the FDA for Hemo-o-lok.

Pre-market Notification Details

Device IDK941972
510k NumberK941972
Device Name:HEMO-O-LOK
ClassificationClip, Implantable
Applicant KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006 -4706
ContactEdward Basile
CorrespondentEdward Basile
KING & SPALDING 1730 PENNSYLVANIA AVENUE, NW Washington,  DC  20006 -4706
Product CodeFZP  
CFR Regulation Number878.4300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-04-22
Decision Date1994-06-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.