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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fastener, Fixation, Nondegradable, Soft Tissue
510(k) Number K062739
Device Name CINCH BONE ANCHOR SYSTEM
Applicant
Sapphire Medical, Inc.
1835 Market St. 28th Floor
Philadelphia,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
Sapphire Medical, Inc.
1835 Market St. 28th Floor
Philadelphia,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number888.3040
Classification Product Code
MBI  
Date Received09/13/2006
Decision Date 02/13/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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