HEYER-SCHUTE UNIVERSAL URETERAL STENT

Catheter, Nephrostomy

AMERICAN HOSPITAL SUPPLY CORP.

The following data is part of a premarket notification filed by American Hospital Supply Corp. with the FDA for Heyer-schute Universal Ureteral Stent.

Pre-market Notification Details

Device IDK823418
510k NumberK823418
Device Name:HEYER-SCHUTE UNIVERSAL URETERAL STENT
ClassificationCatheter, Nephrostomy
Applicant AMERICAN HOSPITAL SUPPLY CORP. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-11-15
Decision Date1982-12-03

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