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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Flowmeter, Calibration, Gas
510(k) Number K953506
Device Name WESTMED RESPIRATORY LUER ADAPTOR
Applicant
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Applicant Contact LYNN D HAYSE
Correspondent
Westmed Intl.
3351 E. Hemisphere Loop
Tucson,  AZ  85706
Correspondent Contact LYNN D HAYSE
Regulation Number868.2350
Classification Product Code
BXY  
Date Received07/26/1995
Decision Date 09/15/1995
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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