SILASTIC U-TUBE KIT

Catheter, Nephrostomy, General & Plastic Surgery

DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS

The following data is part of a premarket notification filed by Dow Corning Corp. Healthcare Industries Materials with the FDA for Silastic U-tube Kit.

Pre-market Notification Details

Device IDK781526
510k NumberK781526
Device Name:SILASTIC U-TUBE KIT
ClassificationCatheter, Nephrostomy, General & Plastic Surgery
Applicant DOW CORNING CORP. HEALTHCARE INDUSTRIES MATERIALS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGBO  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-09-05
Decision Date1978-09-20

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