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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 K901623
Device Name AMBU OXYGEN REGULATOR
Applicant
FLOTEC, INC.
8132 WOODLAND DR.
INDIANAPOLIS,  IN  46278
Applicant Contact C KLOPSTAD
Correspondent
FLOTEC, INC.
8132 WOODLAND DR.
INDIANAPOLIS,  IN  46278
Correspondent Contact C KLOPSTAD
Regulation Number868.2700
Classification Product Code
CAN  
Date Received04/06/1990
Decision Date 04/26/1990
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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