The following data is part of a premarket notification filed by Emtech Laboratories with the FDA for Hearsaver.
| Device ID | K962292 |
| 510k Number | K962292 |
| Device Name: | HEARSAVER |
| Classification | Protector, Hearing (insert) |
| Applicant | EMTECH LABORATORIES RT. 634 AT 760 Hardy, VA 24101 |
| Contact | Louise H Vermillian |
| Correspondent | Louise H Vermillian EMTECH LABORATORIES RT. 634 AT 760 Hardy, VA 24101 |
| Product Code | EWD |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1996-10-29 |