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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Tracheostomy And Tube Cuff
510(k) Number K903699
Device Name PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM
Applicant
Passy & Passy, Inc.
4521 Campus Dr., Suite 273
Irvine,  CA  92715
Applicant Contact PATRICIA E PASSY
Correspondent
Passy & Passy, Inc.
4521 Campus Dr., Suite 273
Irvine,  CA  92715
Correspondent Contact PATRICIA E PASSY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received08/15/1990
Decision Date 09/04/1990
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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