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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Incubator, Neonatal Transport
510(k) Number K081399
Device Name AVIATOR TRANSPORT INCUBATOR
Applicant
International Biomedical, Ltd.
8508 Cross Park Dr.
Austin,  TX  78754
Applicant Contact AMY PIEPER
Correspondent
International Biomedical, Ltd.
8508 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact AMY PIEPER
Regulation Number880.5410
Classification Product Code
FPL  
Date Received05/19/2008
Decision Date 06/06/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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