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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 K850496
Device Name TRANSPORT INCUBATOR 185
Applicant
Airborne Life Support Systems, Inc.
2409 N. Main
Cleburne,  TX  76031
Applicant Contact LADDIE L DAVIS
Correspondent
Airborne Life Support Systems, Inc.
2409 N. Main
Cleburne,  TX  76031
Correspondent Contact LADDIE L DAVIS
Regulation Number880.5410
Classification Product Code
FPL  
Date Received02/08/1985
Decision Date 05/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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