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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 K970365
Device Name PASSY-MUIR O2 ADAPTER; PMA2000
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 Received01/31/1997
Decision Date 02/12/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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