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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 K931346
Device Name FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT
Applicant
Ferno
70 Weil Way
Wilmington,  OH  45177
Applicant Contact ERIC BESANKO
Correspondent
Ferno
70 Weil Way
Wilmington,  OH  45177
Correspondent Contact ERIC BESANKO
Regulation Number880.5410
Classification Product Code
FPL  
Subsequent Product Code
FPO  
Date Received03/17/1993
Decision Date 08/25/1993
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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