The following data is part of a premarket notification filed by Arisil Medical with the FDA for Earclear.
Device ID | K951596 |
510k Number | K951596 |
Device Name: | EARCLEAR |
Classification | Device, Inflation, Middle Ear |
Applicant | ARISIL MEDICAL 450 CLINTON ST. Brooklyn, NY 11231 |
Contact | Daniel S Arick |
Correspondent | Daniel S Arick ARISIL MEDICAL 450 CLINTON ST. Brooklyn, NY 11231 |
Product Code | MJV |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-07 |
Decision Date | 1995-05-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EARCLEAR 98510873 not registered Live/Pending |
Karnezis, Anastasios T 2024-04-20 |