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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 K061785
Device Name CYL-FIL OXYGEN SYSTEM
Applicant
Responsive Respiratory, Inc.
261 Wolfner Dr.
St. Louis,  MO  63026
Applicant Contact THOMAS BANNON
Correspondent
Responsive Respiratory, Inc.
261 Wolfner Dr.
St. Louis,  MO  63026
Correspondent Contact THOMAS BANNON
Regulation Number868.2700
Classification Product Code
CAN  
Date Received06/23/2006
Decision Date 09/07/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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