CATHETERS, SILICONE COATED

Catheter, Urological

PHARMASEAL DIV., BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Pharmaseal Div., Baxter Healthcare Corp. with the FDA for Catheters, Silicone Coated.

Pre-market Notification Details

Device IDK770256
510k NumberK770256
Device Name:CATHETERS, SILICONE COATED
ClassificationCatheter, Urological
Applicant PHARMASEAL DIV., BAXTER HEALTHCARE CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKOD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-02-10
Decision Date1977-02-17

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