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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mask, Oxygen, Low Concentration, Venturi
510(k) Number K781325
Device Name MARKII VENTIMASKS
Applicant
VICKERS AMERICA MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VICKERS AMERICA MEDICAL CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5600
Classification Product Code
BYF  
Date Received08/01/1978
Decision Date 09/27/1978
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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