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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 (w/wo connector)
510(k) Number K851016
Device Name PASSY-MUIR TRACH VALVE
Applicant
PASSY & PASSY, INC.
4521 CAMPUS DRIVE, SUITE 273
IRVINE,  CA  92715
Applicant Contact PATRICIA E PASSY
Correspondent
PASSY & PASSY, INC.
4521 CAMPUS DRIVE, SUITE 273
IRVINE,  CA  92715
Correspondent Contact PATRICIA E PASSY
Regulation Number868.5800
Classification Product Code
BTO  
Date Received03/12/1985
Decision Date 06/07/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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