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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Tubing And Support, Ventilator (W Harness)
510(k) Number K945740
Device Name INFANT FLOW SYSTEM
Applicant
HAMILTON MEDICAL, INC.
P.O. BOX 30008
RENO,  NV  89520
Applicant Contact TIM COWART
Correspondent
HAMILTON MEDICAL, INC.
P.O. BOX 30008
RENO,  NV  89520
Correspondent Contact TIM COWART
Regulation Number868.5975
Classification Product Code
BZO  
Date Received11/23/1994
Decision Date 03/23/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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