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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apparatus, Gas-Scavenging
510(k) Number K953269
Device Name SAFECIRCUIT MANIFOLD/PULMONARY UNIT
Applicant
ADVANCED WARMING SYSTEMS, INC.
3414 22ND ST.
LUBBOCK,  TX  79410
Applicant Contact RANDY HICKLE
Correspondent
ADVANCED WARMING SYSTEMS, INC.
3414 22ND ST.
LUBBOCK,  TX  79410
Correspondent Contact RANDY HICKLE
Regulation Number868.5430
Classification Product Code
CBN  
Date Received07/13/1995
Decision Date 12/20/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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