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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 K962714
Device Name PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
Applicant
PASSY-MUIR, INC.
4521 CAMPUS DR., SUITE 273
IRVINE,  CA  92612
Applicant Contact PATRICIA E PASSY
Correspondent
PASSY-MUIR, INC.
4521 CAMPUS DR., SUITE 273
IRVINE,  CA  92612
Correspondent Contact PATRICIA E PASSY
Regulation Number868.5800
Classification Product Code
JOH  
Date Received07/12/1996
Decision Date 10/28/1996
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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