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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 K894642
Device Name SLEEPAP MASK
Applicant
Medical Industries America, Inc.
713 - 52nd St.
West Des Moines,  IA  50265
Applicant Contact RUSSELL BIRD
Correspondent
Medical Industries America, Inc.
713 - 52nd St.
West Des Moines,  IA  50265
Correspondent Contact RUSSELL BIRD
Regulation Number868.5580
Classification Product Code
BYG  
Date Received07/24/1989
Decision Date 10/19/1989
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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