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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceENDOTRACHEAL TUBE CHANGERS
Generic NameChanger, tube, endotracheal
Regulation Number868.5730
ApplicantInstrumentation Industries, Inc.
1211 St.S Run Rd.
Pittsburg, PA 15236
PMA NumberP800068
Supplement NumberS002
Date Received09/03/1999
Decision Date11/04/1999
Reclassified Date12/09/2004
Product Code LNZ 
Advisory Committee Anesthesiology
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at FBK Medical Tubing, Inc., 511 Cobb St., Birmingham, AL 35209.
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