EXMOOR AURAL GROMMET AG/T2L

Tube, Tympanostomy

EXMOOR PLASTICS LTD.

The following data is part of a premarket notification filed by Exmoor Plastics Ltd. with the FDA for Exmoor Aural Grommet Ag/t2l.

Pre-market Notification Details

Device IDK810702
510k NumberK810702
Device Name:EXMOOR AURAL GROMMET AG/T2L
ClassificationTube, Tympanostomy
Applicant EXMOOR PLASTICS LTD. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-03-16
Decision Date1981-04-14

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