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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 K041311
Device Name TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES)
Applicant
TIGER MEDICAL PRODUCTS LTD
1308 MORNINGSIDE PARK DRIVE
ALPHARETTA,  GA  30022
Applicant Contact JAY MANSOUR
Correspondent
TIGER MEDICAL PRODUCTS LTD
1308 MORNINGSIDE PARK DRIVE
ALPHARETTA,  GA  30022
Correspondent Contact JAY MANSOUR
Regulation Number868.5730
Classification Product Code
BTR  
Date Received05/17/2004
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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