The following data is part of a premarket notification filed by Maico Hearing Instruments, Inc. with the FDA for Star 42 Pp-sp, Star 42 Pp-sl (t100).
Device ID | K931041 |
510k Number | K931041 |
Device Name: | STAR 42 PP-SP, STAR 42 PP-SL (T100) |
Classification | Hearing Aid, Air Conduction |
Applicant | MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
Contact | Thomas A Dold |
Correspondent | Thomas A Dold MAICO HEARING INSTRUMENTS, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 -2029 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-01 |
Decision Date | 1993-06-01 |