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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 K904684
Device Name AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION
Applicant
Amici, Inc.
518 Vincent St.
Spring City,  PA  19475
Applicant Contact MICHAEL BONO
Correspondent
Amici, Inc.
518 Vincent St.
Spring City,  PA  19475
Correspondent Contact MICHAEL BONO
Regulation Number892.1390
Classification Product Code
IYT  
Date Received08/15/1990
Decision Date 01/14/1991
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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