HEMORRHAGE OCCLUDER PIN

Staple, Implantable

TOOLS FOR SURGERY, LLC

The following data is part of a premarket notification filed by Tools For Surgery, Llc with the FDA for Hemorrhage Occluder Pin.

Pre-market Notification Details

Device IDK040109
510k NumberK040109
Device Name:HEMORRHAGE OCCLUDER PIN
ClassificationStaple, Implantable
Applicant TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook,  NY  11790
ContactArnold R Leiboff
CorrespondentArnold R Leiboff
TOOLS FOR SURGERY, LLC 1339 STONY BROOK ROAD Stony Brook,  NY  11790
Product CodeGDW  
CFR Regulation Number878.4750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-20
Decision Date2004-03-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00861838000309 K040109 000
00861838000316 K040109 000
00840319750056 K040109 000
00840319750032 K040109 000

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