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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 K896124
Device Name MEDIPART DISPOSABLE XENON-133 REBREATHING MP-0133
Applicant
Medipart Jerry Alexander
607 Spring Beach Rd.
Cary,  IL  60013
Applicant Contact JERRY ALEXANDER
Correspondent
Medipart Jerry Alexander
607 Spring Beach Rd.
Cary,  IL  60013
Correspondent Contact JERRY ALEXANDER
Regulation Number892.1390
Classification Product Code
IYT  
Date Received10/23/1989
Decision Date 01/22/1990
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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