NELSON-JUNG PLEURAL CATH

Catheter, Peritoneal

RESEARCH MEDICAL, INC.

The following data is part of a premarket notification filed by Research Medical, Inc. with the FDA for Nelson-jung Pleural Cath.

Pre-market Notification Details

Device IDK854812
510k NumberK854812
Device Name:NELSON-JUNG PLEURAL CATH
ClassificationCatheter, Peritoneal
Applicant RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
ContactMichael N Kelly
CorrespondentMichael N Kelly
RESEARCH MEDICAL, INC. 1847 WEST 2300 SOUTH Salt Lake City,  UT  84119
Product CodeGBW  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-12-03
Decision Date1986-02-11

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