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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 K953464
Device Name WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK
Applicant
Westmed, Inc.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Applicant Contact MR. LYNN HAYSE
Correspondent
Westmed, Inc.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Correspondent Contact MR. LYNN HAYSE
Regulation Number868.5580
Classification Product Code
BYG  
Date Received07/24/1995
Decision Date 09/18/1995
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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