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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 K923159
Device Name ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS
Applicant
Arjo-Century, Inc.
8130 Lehigh Ave.
Morton Grove,  IL  60053
Applicant Contact GREGORY D HOLMER
Correspondent
Arjo-Century, Inc.
8130 Lehigh Ave.
Morton Grove,  IL  60053
Correspondent Contact GREGORY D HOLMER
Regulation Number890.5100
Classification Product Code
ILJ  
Date Received06/29/1992
Decision Date 08/06/1992
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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