TURKEL ABDOMINAL PARACENTESIS SYSTEM

Catheter, Irrigation

SYMBIOSIS CORP.

The following data is part of a premarket notification filed by Symbiosis Corp. with the FDA for Turkel Abdominal Paracentesis System.

Pre-market Notification Details

Device IDK924702
510k NumberK924702
Device Name:TURKEL ABDOMINAL PARACENTESIS SYSTEM
ClassificationCatheter, Irrigation
Applicant SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami,  FL  33166
ContactKevin W Smith
CorrespondentKevin W Smith
SYMBIOSIS CORP. 8600 N.W. 41 ST. Miami,  FL  33166
Product CodeGBX  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-09-17
Decision Date1993-01-12

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