NON-STERILE CATHETER REPAIR KITS

Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

EVERMED, INC.

The following data is part of a premarket notification filed by Evermed, Inc. with the FDA for Non-sterile Catheter Repair Kits.

Pre-market Notification Details

Device IDK830406
510k NumberK830406
Device Name:NON-STERILE CATHETER REPAIR KITS
ClassificationCatheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Applicant EVERMED, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLJS  
CFR Regulation Number880.5970 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-07
Decision Date1983-03-01

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