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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Fixation, Bone
510(k) Number K130185
FOIA Releasable 510(k) K130185
Device Name 4WEB OSTEOTOMY BONE WEDGE
Applicant
4-Web, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Applicant Contact RICH JANSEN, PHARM, D.
Correspondent
4-Web, Inc.
13540 Guild Ave.
Apple Valley,  MN  55124
Correspondent Contact RICH JANSEN, PHARM, D.
Regulation Number888.3030
Classification Product Code
HRS  
Date Received01/25/2013
Decision Date 06/07/2013
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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