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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 K990905
Device Name PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
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 Received03/18/1999
Decision Date 06/11/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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