CARE + PLUS IRREGATION TRAY

Catheter, Urological

WELMED SYSTEMS, INC.

The following data is part of a premarket notification filed by Welmed Systems, Inc. with the FDA for Care + Plus Irregation Tray.

Pre-market Notification Details

Device IDK863281
510k NumberK863281
Device Name:CARE + PLUS IRREGATION TRAY
ClassificationCatheter, Urological
Applicant WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey,  NH  03469
ContactDavid B Peters
CorrespondentDavid B Peters
WELMED SYSTEMS, INC. P.O. BOX 599 West Swanzey,  NH  03469
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-08-25
Decision Date1986-10-31

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