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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameENDOTRACHEAL TUBE CHANGERS
Classification Namechanger, tube, endotracheal
Generic Nameendotracheal tube changer
Regulation Number868.5730
ApplicantINSTRUMENTATION INDUSTRIES, INC.
PMA NumberP800068
Supplement NumberS002
Date Received09/03/1999
Decision Date11/04/1999
Product Code
LNZ[ Registered Establishments with LNZ ]
Advisory Committee Anesthesiology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at fbk medical tubing, inc. , 511 cobb st. , birmingham, al 35209.
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