ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493

Set, Administration, For Peritoneal Dialysis, Disposable

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Ultraset/3l Capd Disposable Disconnect Y-set Models 5c4366 & 5c4493.

Pre-market Notification Details

Device IDK961825
510k NumberK961825
Device Name:ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493
ClassificationSet, Administration, For Peritoneal Dialysis, Disposable
Applicant BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactDavid C Ross
CorrespondentDavid C Ross
BAXTER HEALTHCARE CORP. 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
Product CodeKDJ  
CFR Regulation Number876.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-05-10
Decision Date1996-08-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412090080 K961825 000
50085412030574 K961825 000

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