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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Regulator, Pressure, Gas Cylinder
510(k) Number K915505
Device Name REGULATOR FLOWMETER
Applicant
Lifeguard Medical Products, Inc.
6888 Hillsdale Ct.
Indianapolis,  IN  46250
Applicant Contact CRAIG TRIMBLE
Correspondent
Lifeguard Medical Products, Inc.
6888 Hillsdale Ct.
Indianapolis,  IN  46250
Correspondent Contact CRAIG TRIMBLE
Regulation Number868.2700
Classification Product Code
CAN  
Date Received12/09/1991
Decision Date 04/22/1992
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
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