The following data is part of a premarket notification filed by Segi Hearing Aid Co. with the FDA for Intrastar Pre-wired Faceplate For In-the-ear Hearing Aids.
| Device ID | K961593 |
| 510k Number | K961593 |
| Device Name: | INTRASTAR PRE-WIRED FACEPLATE FOR IN-THE-EAR HEARING AIDS |
| Classification | Face Plate Hearing Aid |
| Applicant | SEGI HEARING AID CO. 24 FIFTH AVE. New York, NY 10011 |
| Contact | Leo Weinberger, Esq. |
| Correspondent | Leo Weinberger, Esq. SEGI HEARING AID CO. 24 FIFTH AVE. New York, NY 10011 |
| Product Code | LRB |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-11-07 |
| Summary: | summary |