The following data is part of a premarket notification filed by Richards Medical Co., Inc. with the FDA for Service Master (impulse).
Device ID | K873300 |
510k Number | K873300 |
Device Name: | SERVICE MASTER (IMPULSE) |
Classification | Face Plate Hearing Aid |
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 | LRB |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-18 |
Decision Date | 1987-12-08 |