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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 K061798
Device Name BIOPRO MEMORY STAPLE
Applicant
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Applicant Contact DAVID MRAK
Correspondent
Biopro, Inc.
17 Seventeenth St.
Port Huron,  MI  48060
Correspondent Contact DAVID MRAK
Regulation Number888.3030
Classification Product Code
JDR  
Date Received06/26/2006
Decision Date 08/21/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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