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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 K932417
Device Name FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT
Applicant
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Applicant Contact RENEE WALZ
Correspondent
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Correspondent Contact RENEE WALZ
Regulation Number880.5410
Classification Product Code
FPL  
Date Received05/18/1993
Decision Date 09/09/1993
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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