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 |