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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Tracheal (W/Wo Connector)
510(k) Number K984528
Device Name PARKER FLEX-TIP TRACHEAL TUBE
Applicant
PARKER MEDICAL ASSOC.
109 INVERNESS DRIVE EAST,
SUITE J
ENGLEWOOD,  CO  80112 -5105
Applicant Contact JEFFREY D PARKER
Correspondent
PARKER MEDICAL ASSOC.
109 INVERNESS DRIVE EAST,
SUITE J
ENGLEWOOD,  CO  80112 -5105
Correspondent Contact JEFFREY D PARKER
Regulation Number868.5730
Classification Product Code
BTR  
Date Received12/21/1998
Decision Date 07/15/1999
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
Recalls CDRH Recalls
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