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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prosthesis, hip, cement restrictor
510(k) Number K030608
Device Name OTI BONE CEMENT PLUG
Applicant
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Applicant Contact SAM SON
Correspondent
OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY,  MD  21031 -1201
Correspondent Contact SAM SON
Regulation Number878.3300
Classification Product Code
JDK  
Date Received02/26/2003
Decision Date 06/12/2003
Decision SE - With Limitations (SESU)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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