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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
510(k) Number K760219
Device Name MASKA, OXYGEN VINYL D-SP. SINGLE USE
Applicant
MANNER MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
MANNER MEDICAL PRODUCTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5580
Classification Product Code
BYG  
Date Received07/12/1976
Decision Date 08/03/1976
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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