Female IC (Not Finalized)

Catheter, Straight

Hollister Incorporated

The following data is part of a premarket notification filed by Hollister Incorporated with the FDA for Female Ic (not Finalized).

Pre-market Notification Details

Device IDK213575
510k NumberK213575
Device Name:Female IC (Not Finalized)
ClassificationCatheter, Straight
Applicant Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
ContactMichelle Schiltz-Taing
CorrespondentMichelle Schiltz-Taing
Hollister Incorporated 2000 Hollister Drive Libertyville,  IL  60048
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-10
Decision Date2022-09-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00610075072712 K213575 000
00610075072705 K213575 000
00610075072699 K213575 000
00610075072644 K213575 000

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