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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Condenser, Heat And Moisture (Artificial Nose)
510(k) Number K953619
Device Name WARM N WET HME W/LUER ADAPTER
Applicant
HOSPITAK, INC.
10 DANIEL ST.
FARMINGDALE,  NY  11735
Applicant Contact WILLIAM LACCY
Correspondent
HOSPITAK, INC.
10 DANIEL ST.
FARMINGDALE,  NY  11735
Correspondent Contact WILLIAM LACCY
Regulation Number868.5375
Classification Product Code
BYD  
Date Received08/03/1995
Decision Date 08/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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