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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Board, Scooter, Prone
510(k) Number K841695
Device Name CRAWLER
Applicant
Maddak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Maddak, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5370
Classification Product Code
KNL  
Date Received04/23/1984
Decision Date 05/10/1984
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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