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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K152672
Device Name Cajun Commando 4x4
Applicant
Lil Critter, LLC
2701 Oliver Rd.
Monroe,  LA  71201
Applicant Contact BRENDA BRANT
Correspondent
Lil Critter, LLC
2701 Oliver Rd.
Monroe,  LA  71201
Correspondent Contact BRENDA BRANT
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/18/2015
Decision Date 01/21/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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