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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 K760941
Device Name MASK ARTIFICIAL RESPIRATION
Applicant
GENE R. BALDWIN
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
GENE R. BALDWIN
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5580
Classification Product Code
BYG  
Date Received11/01/1976
Decision Date 01/12/1977
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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