CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED

Catheter, Straight

CURE MEDICAL LLC.

The following data is part of a premarket notification filed by Cure Medical Llc. with the FDA for Cure Catheter Female, Cure Catheter Male, Cure Catheter Coude, Cure Catheter Pediatric, Cure Catheter Hydrophilic Coated.

Pre-market Notification Details

Device IDK132500
510k NumberK132500
Device Name:CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
ClassificationCatheter, Straight
Applicant CURE MEDICAL LLC. 257 GARNET GARDEN STREET Henderson,  NV  89015
ContactJohn Beasley
CorrespondentJohn Beasley
CURE MEDICAL LLC. 257 GARNET GARDEN STREET Henderson,  NV  89015
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-09
Decision Date2013-12-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20815947021223 K132500 000
20815947020301 K132500 000
20815947020318 K132500 000
20815947020325 K132500 000
00815947020338 K132500 000
20815947020349 K132500 000
20815947020356 K132500 000
20815947020998 K132500 000
20815947021001 K132500 000
20815947021018 K132500 000
20815947020981 K132500 000

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