The following data is part of a premarket notification filed by Spectro Industries, Inc. with the FDA for Kanievski Sensory Aid Or Device.
| Device ID | K843433 |
| 510k Number | K843433 |
| Device Name: | KANIEVSKI SENSORY AID OR DEVICE |
| Classification | Hearing Aid, Tactile |
| Applicant | SPECTRO INDUSTRIES, INC. JENKINTOWN PLAZA Jenkintown, PA 19046 |
| Contact | Joseph A Goldblum |
| Correspondent | Joseph A Goldblum SPECTRO INDUSTRIES, INC. JENKINTOWN PLAZA Jenkintown, PA 19046 |
| Product Code | LRA |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-04 |
| Decision Date | 1984-11-14 |