The following data is part of a premarket notification filed by Marketing Specialist, Inc. with the FDA for Hearing Aid (all-in-the-ear).
Device ID | K872212 |
510k Number | K872212 |
Device Name: | HEARING AID (ALL-IN-THE-EAR) |
Classification | Hearing Aid, Air Conduction |
Applicant | MARKETING SPECIALIST, INC. 101 NORTH MAIN ST. Du Bois, PA 15801 |
Contact | Ricky A Pape |
Correspondent | Ricky A Pape MARKETING SPECIALIST, INC. 101 NORTH MAIN ST. Du Bois, PA 15801 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-09 |
Decision Date | 1987-07-10 |