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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 K872920
Device Name AMICI KRYPTON ADMINISTRATION SYSTEM*
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 Received07/27/1987
Decision Date 02/12/1988
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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