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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical, Polymeric
510(k) Number K990930
Device Name 3D ANATOMICAL MESH
Applicant
Santerra Medical Technology, Inc.
5451 Hilltop Ave.
Lake Elmo,  MN  55042 -9539
Applicant Contact DAVID P LANG
Correspondent
Santerra Medical Technology, Inc.
5451 Hilltop Ave.
Lake Elmo,  MN  55042 -9539
Correspondent Contact DAVID P LANG
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/19/1999
Decision Date 06/17/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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