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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Powered
510(k) Number K935509
Device Name HYDROTRACK
Applicant
Ferno Ille
70 Weil Way
Wilmington,  OH  45177
Applicant Contact RENEE WALZ
Correspondent
Ferno Ille
70 Weil Way
Wilmington,  OH  45177
Correspondent Contact RENEE WALZ
Regulation Number890.5380
Classification Product Code
BXB  
Date Received11/15/1993
Decision Date 10/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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