The following data is part of a premarket notification filed by 3m Medical Products Group with the FDA for 3m(tm) Ear Impression Material.
Device ID | K945726 |
510k Number | K945726 |
Device Name: | 3M(TM) EAR IMPRESSION MATERIAL |
Classification | Hearing Aid, Air Conduction |
Applicant | 3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-6A-19 St. Paul, MN 55144 -1000 |
Contact | Joyce Eyerly |
Correspondent | Joyce Eyerly 3M MEDICAL PRODUCTS GROUP 3M CENTER, BUILDING 260-6A-19 St. Paul, MN 55144 -1000 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-22 |
Decision Date | 1995-01-27 |