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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 K911717
Device Name ADG INTRAMEDULLARY BONE PLUG - VENTED
Applicant
American Design Group, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Applicant Contact DAVID W SCHLERF
Correspondent
American Design Group, Inc.
C/O Buckman Co.Inc.
1000 Burnett Ave.Suite 250
Concord,  CA  94520
Correspondent Contact DAVID W SCHLERF
Regulation Number878.3300
Classification Product Code
LZN  
Date Received04/17/1991
Decision Date 09/04/1991
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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