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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laryngostroboscope
510(k) Number K921184
Device Name RLS 9100 RHINO-LARYNGEAL STROBOSCOPE
Applicant
Kay Elemetrics Corp.
12 Maple Ave.
P.O. Box 2025
Pine Brook,  NJ  07058
Applicant Contact WILLIAM HARBESON
Correspondent
Kay Elemetrics Corp.
12 Maple Ave.
P.O. Box 2025
Pine Brook,  NJ  07058
Correspondent Contact WILLIAM HARBESON
Regulation Number874.4750
Classification Product Code
EQL  
Date Received03/09/1992
Decision Date 05/28/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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