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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 K861645
Device Name MICRO-TRACHEOSTOMY CARE KIT
Applicant
Aci Medical, Inc.
8835 Mulberry Dr.
P.O. Box 1134
Sunland,  CA  91040
Applicant Contact EDWARD J ARKANS
Correspondent
Aci Medical, Inc.
8835 Mulberry Dr.
P.O. Box 1134
Sunland,  CA  91040
Correspondent Contact EDWARD J ARKANS
Regulation Number868.5800
Classification Product Code
BTO  
Date Received04/30/1986
Decision Date 05/09/1986
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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