The following data is part of a premarket notification filed by Siemens Hearing Instruments, Inc. with the FDA for Siemens Silicone Impression Material.
| Device ID | K872152 |
| 510k Number | K872152 |
| Device Name: | SIEMENS SILICONE IMPRESSION MATERIAL |
| Classification | Hearing Aid, Air Conduction |
| Applicant | SIEMENS HEARING INSTRUMENTS, INC. 685 LIBERTY AVE. Union, NJ 07083 |
| Contact | Leo F Harkins |
| Correspondent | Leo F Harkins SIEMENS HEARING INSTRUMENTS, INC. 685 LIBERTY AVE. Union, NJ 07083 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-04 |
| Decision Date | 1987-08-11 |