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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 K863778
Device Name VENTICIS II
Applicant
Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Applicant Contact MALAMUD, PHD
Correspondent
Cis-Us, Inc.
1983 Marcus Ave.
Lake Success,  NY  11042
Correspondent Contact MALAMUD, PHD
Regulation Number892.1390
Classification Product Code
IYT  
Date Received09/26/1986
Decision Date 10/27/1986
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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