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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tips And Pads, Cane, Crutch And Walker
510(k) Number K831149
Device Name PERSONAL KNEE CRUTCH PAD
Applicant
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Correspondent
Tecnol New Jersey Wound Care, Inc.
368 Fairview Ave.
Hammonton,  NJ  08037
Regulation Number890.3790
Classification Product Code
INP  
Date Received04/08/1983
Decision Date 05/03/1983
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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