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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Suction, Tracheobronchial
510(k) Number K982945
Device Name DUAL PURPOSE CLOSED CATHETER
Applicant
Spirit Medical Systems, Inc.
16267 Whitestone Dr.
Parker,  CO  80134
Applicant Contact JEFF SAWYER
Correspondent
Spirit Medical Systems, Inc.
16267 Whitestone Dr.
Parker,  CO  80134
Correspondent Contact JEFF SAWYER
Regulation Number868.6810
Classification Product Code
BSY  
Date Received08/21/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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