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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Ent Manual Surgical
510(k) Number K970018
Device Name FAST TRACT TRANSTRACHEAL PROCEDURE KIT
Applicant
L.W. Ward and Assoc., Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Applicant Contact LEWIS W WARD
Correspondent
L.W. Ward and Assoc., Inc.
4655 Kirkwood Ct.
Boulder,  CO  80301
Correspondent Contact LEWIS W WARD
Regulation Number874.4420
Classification Product Code
LRC  
Date Received01/02/1997
Decision Date 03/28/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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