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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 K811301
Device Name TUBMATE
Applicant
American Stair-Glide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Stair-Glide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5050
Classification Product Code
ILS  
Date Received05/11/1981
Decision Date 05/27/1981
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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