FLEX-NECK ARC CATHETER

Catheter, Peritoneal, Long-term Indwelling

MEDIGROUP, INC.

The following data is part of a premarket notification filed by Medigroup, Inc. with the FDA for Flex-neck Arc Catheter.

Pre-market Notification Details

Device IDK070730
510k NumberK070730
Device Name:FLEX-NECK ARC CATHETER
ClassificationCatheter, Peritoneal, Long-term Indwelling
Applicant MEDIGROUP, INC. 14 A STONEHILL RD. Oswego,  IL  60543
ContactJohn A Navis
CorrespondentJohn A Navis
MEDIGROUP, INC. 14 A STONEHILL RD. Oswego,  IL  60543
Product CodeFJS  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-03-15
Decision Date2007-07-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450330231 K070730 000
10884450170233 K070730 000
10884450170240 K070730 000
10884450170318 K070730 000
10884450170356 K070730 000
10884450330187 K070730 000
10884450330194 K070730 000
10884450330200 K070730 000
10884450330217 K070730 000
10884450170226 K070730 000

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