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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airway, Esophageal (Obturator)
510(k) Number K894032
Device Name EVAC-TUBE
Applicant
Sharn, Inc.
4801 George Rd., #180
Tampa,  FL  33634
Applicant Contact BRUCE A TOMLINSON
Correspondent
Sharn, Inc.
4801 George Rd., #180
Tampa,  FL  33634
Correspondent Contact BRUCE A TOMLINSON
Regulation Number868.5650
Classification Product Code
CAO  
Date Received06/06/1989
Decision Date 08/31/1989
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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