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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 K811677
Device Name KRYPTON CART
Applicant
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MEDI-PHYSICS INC. DBA NYCOMED AMERSHAM IMAGING
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number892.6500
Classification Product Code
KPY  
Date Received06/15/1981
Decision Date 07/02/1981
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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