510(k) K961593
- Device
- INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS
- Applicant
- SEGI HEARING AID CO.
- 510(k) number
- K961593
- Product code
- LRB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-11-07
- Date received
- 1996-04-24
- Regulation
- 874.3300
- Classification name
- Face Plate Hearing Aid
- Medical specialty
- Ear Nose & Throat
- Review panel
- Ear Nose & Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LEO WEINBERGER, ESQ.
- Address
- 24 Fifth Ave. New York NY US 10011 10011
FDA Registration Numbers#
- 3005706667
- 3010197022
- 3043149272
- 3038310428
- 3010408889
- 3008606477
- 3005465494
- 1052698
- 3003303986
- 3026048380
- 1044692
- 2240713
- 3009307953
- 3005650109
- 3030396448
- 3008460009
- 3011927597
- 3017441596
- 3007694978
- 3014844046
- 3020998569
Source Documents#
Other 510(k) Records For Product Code LRB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K974219 | FACEPLATE ASSEMBLY | Finetone Hearing Instruments | 1998-02-20 |
| K942722 | MODULE PROGRAM | Electone, Inc. | 1994-09-06 |
| K942236 | AUDINA PREWIRES (FACEPLATE HEARING AID SERIES) | Audina Hearing Instrument | 1994-06-17 |
| K935048 | ARTISAN PROGRAMMER & HEARING AID | Telex Communications, Inc. | 1994-02-09 |
| K933038 | GOLD AF MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933046 | SILVER L MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933045 | SILVER RECHARGEABLE MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933044 | SILVER LD MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933043 | SILVER PPP MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933040 | GOLD CD MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933039 | GOLD L MODULE, ITE | Electone, Inc. | 1993-08-02 |
| K933037 | GOLD K AMP, ITE | Electone, Inc. | 1993-08-02 |
| K910901 | FACEPLATE ITE HEARING AID MODEL 28A | Telex Communications, Inc. | 1991-05-30 |
| K910900 | FACEPLATE ITE HEARING AID MODEL TCA | Telex Communications, Inc. | 1991-05-30 |
| K897023 | OVERSIGHT PROGRAM FOR IN-OFFICE ASSEMBLY, HRNG AID | Audina Hearing Instrument | 1990-03-16 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases