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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electroglottograph
510(k) Number K990240
Device Name ELECTROGLOTTOGRAPH
Applicant
Kay Elemetrics Corp.
2 Bridgewater Ln.
Lincoln Park,  NJ  07035
Applicant Contact WILLIAM D HARBESON
Correspondent
Kay Elemetrics Corp.
2 Bridgewater Ln.
Lincoln Park,  NJ  07035
Correspondent Contact WILLIAM D HARBESON
Regulation Number874.1325
Classification Product Code
KLX  
Date Received01/25/1999
Decision Date 03/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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