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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K924367
Device Name OGDEN ANCHOR
Applicant
Advanced Surgical Implants, Inc.
7410 Cross County Rd., Suite E
North Charleston,  SC  29418
Applicant Contact BRUCE F MEADOWS
Correspondent
Advanced Surgical Implants, Inc.
7410 Cross County Rd., Suite E
North Charleston,  SC  29418
Correspondent Contact BRUCE F MEADOWS
Regulation Number888.3030
Classification Product Code
JDR  
Date Received08/28/1992
Decision Date 07/26/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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