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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Shield, Protective, Personnel
510(k) Number K791522
Device Name FLOW MEDICAL X-RAY PROTECTIVE GLOVES
Applicant
Flow X-Ray Corp.
55 Northeren Blvd., Suite 200
Great Neck,  NY  11021
Correspondent
Flow X-Ray Corp.
55 Northeren Blvd., Suite 200
Great Neck,  NY  11021
Regulation Number892.6500
Classification Product Code
KPY  
Date Received08/10/1979
Decision Date 10/26/1979
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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