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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bath, Sitz, Powered
510(k) Number K823327
Device Name PORTABLE SHOWER BATH
Applicant
Wall Manufacturer, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Wall Manufacturer, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number890.5100
Classification Product Code
ILM  
Date Received11/08/1982
Decision Date 12/07/1982
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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