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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adaptor, Hygiene
510(k) Number K802511
Device Name GARELICK COMMODE
Applicant
Garelick Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Garelick Mfg. Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
ILS  
Date Received10/15/1980
Decision Date 11/12/1980
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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