3M(TM) EAR IMPRESSION MATERIAL

Hearing Aid, Air Conduction

3M MEDICAL PRODUCTS GROUP

The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m(tm) Ear Impression Material.

Pre-market Notification Details

Device IDK945726
510k NumberK945726
Device Name:3M(TM) EAR IMPRESSION MATERIAL
ClassificationHearing Aid, Air Conduction
Applicant 3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-6A-19 St. Paul,  MN  55144 -1000
ContactJoyce Eyerly
CorrespondentJoyce Eyerly
3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-6A-19 St. Paul,  MN  55144 -1000
Product CodeESD  
CFR Regulation Number874.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-22
Decision Date1995-01-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.