The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Post Auricular Hearing Aid 46pp-pc Summit.
Device ID | K874707 |
510k Number | K874707 |
Device Name: | POST AURICULAR HEARING AID 46PP-PC SUMMIT |
Classification | Hearing Aid, Air Conduction |
Applicant | RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Contact | Robert F Games |
Correspondent | Robert F Games RICHARDS MEDICAL CO., INC. 1450 BROOKS RD. Memphis, TN 38116 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-17 |
Decision Date | 1987-12-11 |