The following data is part of a premarket notification filed by Ear Technology Corp. with the FDA for Dry & Store.
Device ID | K972776 |
510k Number | K972776 |
Device Name: | DRY & STORE |
Classification | Hearing Aid, Air Conduction |
Applicant | EAR TECHNOLOGY CORP. 207 EAST MYRTLE AVE. Johnson City, TN 37601 |
Contact | Richard J Gilbert |
Correspondent | Richard J Gilbert EAR TECHNOLOGY CORP. 207 EAST MYRTLE AVE. Johnson City, TN 37601 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-07-25 |
Decision Date | 1997-09-08 |
Summary: | summary |