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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 K923637
Device Name ARJO-CENTURY ARM AND LEG TANK SYSTEM
Applicant
Arjo-Century, Inc.
8130 Lehigh Ave.
Morton Grove,  IL  60053
Applicant Contact GREGORY HOMER
Correspondent
Arjo-Century, Inc.
8130 Lehigh Ave.
Morton Grove,  IL  60053
Correspondent Contact GREGORY HOMER
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received07/21/1992
Decision Date 02/12/1993
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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