NELATON-, FEMALE - OR TIEMANN CATHETER

Catheter, Urological

UNOPLAST A/S

The following data is part of a premarket notification filed by Unoplast A/s with the FDA for Nelaton-, Female - Or Tiemann Catheter.

Pre-market Notification Details

Device IDK896729
510k NumberK896729
Device Name:NELATON-, FEMALE - OR TIEMANN CATHETER
ClassificationCatheter, Urological
Applicant UNOPLAST A/S DK-3390 HUNDESTED Denmark,  DK
ContactErik Andersen
CorrespondentErik Andersen
UNOPLAST A/S DK-3390 HUNDESTED Denmark,  DK
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-11-30
Decision Date1990-11-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00768455145591 K896729 000
00768455145492 K896729 000
00768455145546 K896729 000
00768455145553 K896729 000
00768455145607 K896729 000
00768455145485 K896729 000
00768455145577 K896729 000
00768455145447 K896729 000
00768455145461 K896729 000
00768455145478 K896729 000
00768455145539 K896729 000
00768455145560 K896729 000
00768455145584 K896729 000
00768455145454 K896729 000

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