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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hearing Aid, Tactile
510(k) Number K843433
Device Name KANIEVSKI SENSORY AID OR DEVICE
Applicant
Spectro Industries, Inc.
Jenkintown Plz.
Jenkintown,  PA  19046
Applicant Contact JOSEPH A GOLDBLUM
Correspondent
Spectro Industries, Inc.
Jenkintown Plz.
Jenkintown,  PA  19046
Correspondent Contact JOSEPH A GOLDBLUM
Classification Product Code
LRA  
Date Received09/04/1984
Decision Date 11/14/1984
Decision Substantially Equivalent (SESE)
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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