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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 K781741
Device Name MASK, BI FLO NASAL OXYGEN
Applicant
Inhal-O-Tech Medical Plastic
P.O. Box 385
Blue Springs,  MO  64015
Applicant Contact J.W. Brown
Correspondent
Inhal-O-Tech Medical Plastic
P.O. Box 385
Blue Springs,  MO  64015
Correspondent Contact J.W. Brown
Regulation Number868.5580
Classification Product Code
BYG  
Date Received10/07/1978
Decision Date 12/01/1978
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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