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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 K831028
Device Name TI-1000 TRANSPORT INCUBATOR
Applicant
Narco Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Narco Scientific
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5410
Classification Product Code
FPL  
Date Received03/30/1983
Decision Date 05/09/1983
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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