The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Model 284 Pp-agc.
Device ID | K893574 |
510k Number | K893574 |
Device Name: | SIEMENS MODEL 284 PP-AGC |
Classification | Hearing Aid, Air Conduction |
Applicant | SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
Contact | Pamela Branderbit |
Correspondent | Pamela Branderbit SIEMENS HEARING INSTRUMENTS, INC. 10 CORPORATE PLACE SOUTH CORPORATE PARK 287 Piscataway, NJ 08854 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-09 |
Decision Date | 1990-05-21 |