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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stethoscope, Esophageal
510(k) Number K860558
Device Name ESOPHAGEAL STETHOSCOPE
Applicant
Sharn, Inc.
1300 N. Westshore Blvd.
Tampa,  FL  33607
Applicant Contact BRUCE A TOMLINSON
Correspondent
Sharn, Inc.
1300 N. Westshore Blvd.
Tampa,  FL  33607
Correspondent Contact BRUCE A TOMLINSON
Regulation Number868.1910
Classification Product Code
BZW  
Date Received02/14/1986
Decision Date 04/01/1986
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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