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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chair, With Casters
510(k) Number K922045
Device Name SHOWER CHAIRS
Applicant
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Applicant Contact KOTULA COOK
Correspondent
Medical Device Inspection Co., Inc.
55 Northern Blvd., Suite 301
Great Neck,  NY  11021
Correspondent Contact KOTULA COOK
Regulation Number890.3100
Classification Product Code
INM  
Date Received05/01/1992
Decision Date 05/26/1992
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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