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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screen, Leaded, Operator Radiation Protector
510(k) Number K861019
Device Name CEILING MOUNT COUNTERPOISED SECON RADIATION SHIELD
Applicant
Phase One Disign Co.
1455-I E. Francisco Blvd.
San Rafael,  CA  94901
Applicant Contact MELVIN MAGLIOCCO
Correspondent
Phase One Disign Co.
1455-I E. Francisco Blvd.
San Rafael,  CA  94901
Correspondent Contact MELVIN MAGLIOCCO
Regulation Number892.6500
Classification Product Code
EAK  
Date Received03/18/1986
Decision Date 04/02/1986
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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