EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS

Prosthesis, Partial Ossicular Replacement

EXMOOR PLASTICS LTD.

The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Teflon Loop Replacement Prosthesis.

Pre-market Notification Details

Device IDK981045
510k NumberK981045
Device Name:EXMOOR TEFLON LOOP REPLACEMENT PROSTHESIS
ClassificationProsthesis, Partial Ossicular Replacement
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 CodeETB  
CFR Regulation Number874.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-03-20
Decision Date1998-05-20
Summary:summary

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