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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Hydro-Massage
510(k) Number K980033
Device Name FERNO HEALTHCARE RECLINE-A-BATH 2
Applicant
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Applicant Contact ERIC N BESANKO
Correspondent
FERNO-WASHINGTON, INC.
70 WEIL WAY
WILMINGTON,  OH  45177
Correspondent Contact ERIC N BESANKO
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received01/05/1998
Decision Date 04/21/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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