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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Eye, Radiological
510(k) Number K934459
Device Name MED-GENESIS PATIENT LASER EYE SHIELD
Applicant
Med-Genesis, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Applicant Contact CAROLANN KOTULA-COOK
Correspondent
Med-Genesis, Inc.
55 Northern Blvd., Suite 410
Great Neck,,  NY  11021
Correspondent Contact CAROLANN KOTULA-COOK
Regulation Number892.6500
Classification Product Code
IWS  
Date Received09/10/1993
Decision Date 02/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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