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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
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