KANIEVSKI SENSORY AID OR DEVICE

Hearing Aid, Tactile

SPECTRO INDUSTRIES, INC.

The following data is part of a premarket notification filed by Spectro Industries, Inc. with the FDA for Kanievski Sensory Aid Or Device.

Pre-market Notification Details

Device IDK843433
510k NumberK843433
Device Name:KANIEVSKI SENSORY AID OR DEVICE
ClassificationHearing Aid, Tactile
Applicant SPECTRO INDUSTRIES, INC. JENKINTOWN PLAZA Jenkintown,  PA  19046
ContactJoseph A Goldblum
CorrespondentJoseph A Goldblum
SPECTRO INDUSTRIES, INC. JENKINTOWN PLAZA Jenkintown,  PA  19046
Product CodeLRA  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-04
Decision Date1984-11-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.