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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 K760518
Device Name ADAPTER, PER-CEN-TOX-BODY
Applicant
LANDMARK PLASTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
LANDMARK PLASTICS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5600
Classification Product Code
BYF  
Date Received08/26/1976
Decision Date 09/03/1976
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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