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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 K931611
Device Name PERCUTANEOUS TRACHEOSTOMY TUBE KIT
Applicant
Crandall Medical Devices
3129 Yukon Ave.
Costa Mesa,  CA  92626
Applicant Contact NORMAN CRANDALL
Correspondent
Crandall Medical Devices
3129 Yukon Ave.
Costa Mesa,  CA  92626
Correspondent Contact NORMAN CRANDALL
Regulation Number868.5800
Classification Product Code
JOH  
Date Received04/01/1993
Decision Date 08/27/1993
Decision Substantially Equivalent - Kit (SESK)
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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