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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Specimen Collection
510(k) Number K854719
Device Name LUNG CARE (SPECIMEN TRANSPORT & STORAGE CONTAINER)
Applicant
Xsirius Scientific, Inc.
Tobias Klinger
3345 Wilshire Blvd., Suite 307
Los Angeles,  CA  90010
Applicant Contact & GLASSMAN
Correspondent
Xsirius Scientific, Inc.
Tobias Klinger
3345 Wilshire Blvd., Suite 307
Los Angeles,  CA  90010
Correspondent Contact & GLASSMAN
Regulation Number866.2900
Classification Product Code
LIO  
Date Received11/22/1985
Decision Date 02/24/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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