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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 K971348
Device Name FASTTRACH SINGLE-PASS TRACHEAL/ESOPHAGEAL AIRWAY SYSTEM
Applicant
Green Field Medical Sourcing, Inc.
910 Boston Turnpike Rd.
Shrewsbury,  MA  01545
Applicant Contact DONALD R GORSUCH
Correspondent
Green Field Medical Sourcing, Inc.
910 Boston Turnpike Rd.
Shrewsbury,  MA  01545
Correspondent Contact DONALD R GORSUCH
Regulation Number868.5650
Classification Product Code
CAO  
Date Received04/10/1997
Decision Date 02/27/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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