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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 K022876
Device Name MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
Applicant
International Biomedical, Inc.
8508 Cross Park Dr.
Austin,  TX  78754
Applicant Contact GERLAD MANNING
Correspondent
International Biomedical, Inc.
8508 Cross Park Dr.
Austin,  TX  78754
Correspondent Contact GERLAD MANNING
Regulation Number880.5410
Classification Product Code
FPL  
Date Received08/30/2002
Decision Date 09/11/2002
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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