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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gauge, Measuring
510(k) Number K904469
Device Name EYEOPENER
Applicant
Kc Medical Industries
509 S. Washburn St.
Oshkosh,  WI  54904
Applicant Contact JEAN E KEEN
Correspondent
Kc Medical Industries
509 S. Washburn St.
Oshkosh,  WI  54904
Correspondent Contact JEAN E KEEN
Regulation Number874.4420
Classification Product Code
JYJ  
Date Received10/01/1990
Decision Date 06/28/1991
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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