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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wax, Bone
510(k) Number K050292
Device Name SHARPOINT LUKENS BONE WAX
Applicant
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Applicant Contact ELIZABETH LAZARO
Correspondent
Surgical Specialties Corp
100 Dennis Dr.
Reading,  PA  19606
Correspondent Contact ELIZABETH LAZARO
Classification Product Code
MTJ  
Date Received02/07/2005
Decision Date 03/09/2005
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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