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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Surgical With Orthopedic Accessories, Manual
510(k) Number K891917
Device Name ORTHO-J, INC. BEK-JS-004
Applicant
Ortho-J, Inc.
Attorney At Law
1206 N. Ridge Ave.
Tifton,  GA  31793
Applicant Contact HUGH GORDON
Correspondent
Ortho-J, Inc.
Attorney At Law
1206 N. Ridge Ave.
Tifton,  GA  31793
Correspondent Contact HUGH GORDON
Regulation Number878.4950
Classification Product Code
JEB  
Date Received03/27/1989
Decision Date 05/26/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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