PFLEIDERER'S INTRATYMPANIC CATHETER

Tube, Tympanostomy

EXMOOR PLASTICS LTD.

The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Pfleiderer's Intratympanic Catheter.

Pre-market Notification Details

Device IDK974008
510k NumberK974008
Device Name:PFLEIDERER'S INTRATYMPANIC CATHETER
ClassificationTube, Tympanostomy
Applicant EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset,  GB Ta1 2lb
ContactMargaret Blackmore
CorrespondentMargaret Blackmore
EXMOOR PLASTICS LTD. LISIEUX WAY Taunton, Somerset,  GB Ta1 2lb
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-17
Decision Date1998-05-13
Summary:summary

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