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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cement Obturator
510(k) Number K955631
Device Name ORTHOPLUG HARD BONE DESIGN
Applicant
Sunmed, Inc.
3711 Meadowview Dr., Suite 100
Redding,  CA  96002
Applicant Contact RONALD M CARN
Correspondent
Sunmed, Inc.
3711 Meadowview Dr., Suite 100
Redding,  CA  96002
Correspondent Contact RONALD M CARN
Regulation Number878.3300
Classification Product Code
LZN  
Date Received12/11/1995
Decision Date 02/27/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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