PULLEN PLASTIC-PORE PLUGS

Tube, Tympanostomy

RICHARD'S MEDICAL EQUIP., INC.

The following data is part of a premarket notification filed by Richard's Medical Equip., Inc. with the FDA for Pullen Plastic-pore Plugs.

Pre-market Notification Details

Device IDK772066
510k NumberK772066
Device Name:PULLEN PLASTIC-PORE PLUGS
ClassificationTube, Tympanostomy
Applicant RICHARD'S MEDICAL EQUIP., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeETD  
CFR Regulation Number874.3880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-11-01
Decision Date1977-12-20

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