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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Splint, Extremity, Noninflatable, External, Sterile
510(k) Number K924984
Device Name SPECIALIST(R) WALKER
Applicant
Johnson & Johnson Orthopaedics, Inc.
Raynham,  MA  02767
Applicant Contact MARSHA J STONE
Correspondent
Johnson & Johnson Orthopaedics, Inc.
Raynham,  MA  02767
Correspondent Contact MARSHA J STONE
Regulation Number878.3910
Classification Product Code
FYH  
Date Received10/01/1992
Decision Date 02/01/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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