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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 K925249
Device Name CMI STOMA COVERS
Applicant
Community Medical Center
Grand Ave.
P.O. Box 8241
Spokane,  WA  99203
Applicant Contact BRIAN SHUTE
Correspondent
Community Medical Center
Grand Ave.
P.O. Box 8241
Spokane,  WA  99203
Correspondent Contact BRIAN SHUTE
Regulation Number868.5800
Classification Product Code
BTO  
Date Received10/16/1992
Decision Date 12/03/1992
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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