VENTILATION TUBE SILICONE PAPARELLA TYPE

Tube, Tympanostomy

XOMED, INC.

The following data is part of a premarket notification filed by Xomed, Inc. with the FDA for Ventilation Tube Silicone Paparella Type.

Pre-market Notification Details

Device IDK781260
510k NumberK781260
Device Name:VENTILATION TUBE SILICONE PAPARELLA TYPE
ClassificationTube, Tympanostomy
Applicant XOMED, INC. 1318 LONEDELL RD. Arnold,  MO  63010
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-07-24
Decision Date1978-08-14

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