ORLOCATE SYSTEM MODEL ORL 100

Counter, Sponge, Surgical

HALDOR ADVANCED TECHNOLOGIES LTD

The following data is part of a premarket notification filed by Haldor Advanced Technologies Ltd with the FDA for Orlocate System Model Orl 100.

Pre-market Notification Details

Device IDK100551
510k NumberK100551
Device Name:ORLOCATE SYSTEM MODEL ORL 100
ClassificationCounter, Sponge, Surgical
Applicant HALDOR ADVANCED TECHNOLOGIES LTD 107 SHAVEY TZION Pardes Hanna,  IL 37052
ContactSarit Gelbart Gal-rom
CorrespondentSarit Gelbart Gal-rom
HALDOR ADVANCED TECHNOLOGIES LTD 107 SHAVEY TZION Pardes Hanna,  IL 37052
Product CodeLWH  
CFR Regulation Number880.2740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-26
Decision Date2010-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060356150229 K100551 000
00724995220648 K100551 000
00724995243654 K100551 000
00724995243678 K100551 000
00724995243685 K100551 000
00724995243692 K100551 000
00724995220631 K100551 000
00724995230050 K100551 000
00724995220662 K100551 000
00724995220624 K100551 000
00724995220679 K100551 000
05060356150205 K100551 000
05060356150212 K100551 000
00724995243630 K100551 000

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