The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Programmable Auditory Comparator, Modification.
| Device ID | K911726 |
| 510k Number | K911726 |
| Device Name: | PROGRAMMABLE AUDITORY COMPARATOR, MODIFICATION |
| Classification | Hearing Aid, Master |
| Applicant | BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Contact | Terrence E Martin |
| Correspondent | Terrence E Martin BAUSCH & LOMB, INC. 5243 ROYAL WOODS PKWY., #100 Tucker, GA 30084 |
| Product Code | KHL |
| CFR Regulation Number | 874.3330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-10-23 |