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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 K863711
Device Name REGULATOR OXYGEN MECHANICAL
Applicant
Lifeguard Medical Products, Inc.
7476 Shadeland Station Way
Indianapolis,  IN  46256
Applicant Contact BETTY BRUNER
Correspondent
Lifeguard Medical Products, Inc.
7476 Shadeland Station Way
Indianapolis,  IN  46256
Correspondent Contact BETTY BRUNER
Regulation Number868.2700
Classification Product Code
CAN  
Date Received09/23/1986
Decision Date 01/27/1987
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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