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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 K920540
Device Name RADIOLOGICAL PROTECTIVE EYE SHIELD
Applicant
Burkhart Roentgen Intl., Inc.
6571 43rd St., N.
Unit 1704-1706
Pinellas Park,  FL  34665
Applicant Contact NORMAN JACKVONY
Correspondent
Burkhart Roentgen Intl., Inc.
6571 43rd St., N.
Unit 1704-1706
Pinellas Park,  FL  34665
Correspondent Contact NORMAN JACKVONY
Regulation Number892.6500
Classification Product Code
IWS  
Date Received02/05/1992
Decision Date 05/28/1992
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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