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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Rebreathing, Radionuclide
510(k) Number K953513
Device Name XENON CIRCUIT
Applicant
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Applicant Contact MICHAEL A LEAGRE
Correspondent
King Systems Corp.
15011 Herriman Blvd.
P.O. Box 1138
Noblesville,  IN  46060
Correspondent Contact MICHAEL A LEAGRE
Regulation Number892.1390
Classification Product Code
IYT  
Date Received07/26/1995
Decision Date 11/03/1995
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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