FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560

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 Exxtended Peritoneal Dialysis Catheter And Accessories, Model Cf-5560.

Pre-market Notification Details

Device IDK071167
510k NumberK071167
Device Name:FLEX-NECK EXXTENDED PERITONEAL DIALYSIS CATHETER AND ACCESSORIES, MODEL CF-5560
ClassificationCatheter, Peritoneal, Long-term Indwelling
Applicant MEDIGROUP, INC. 14 A STONEHILL RD. Oswego,  IL  60543 -9400
ContactJohn A Navis
CorrespondentJohn A Navis
MEDIGROUP, INC. 14 A STONEHILL RD. Oswego,  IL  60543 -9400
Product CodeFJS  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-26
Decision Date2007-08-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20884450334120 K071167 000
10884450330248 K071167 000
20884450276994 K071167 000
20884450276987 K071167 000
20884450252240 K071167 000
20884450170254 K071167 000

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