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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 K820143
Device Name XENON DELIVERY SYSTEM
Applicant
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Applicant Contact Not Provided
Correspondent
Vital Signs, Inc.
1 Madison St.
East Rutherford,  NJ  07073
Correspondent Contact Not Provided
Regulation Number892.1390
Classification Product Code
IYT  
Date Received01/19/1982
Decision Date 03/02/1982
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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