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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 K760329
Device Name MASK, DISPOSABLE OXYGEN THERAPY
Applicant
INHAL-O-TECH MEDICAL PLASTIC
P.O. Box 385
Blue Spring,  MO  64015
Applicant Contact Joseph W Brown
Correspondent
INHAL-O-TECH MEDICAL PLASTIC
P.O. Box 385
Blue Springs,  MO  64015
Correspondent Contact Joseph W Brown
Regulation Number868.5580
Classification Product Code
BYG  
Date Received07/28/1976
Decision Date 09/30/1976
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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