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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Sphere
510(k) Number K070130
Device Name ORBITAL RECONSTRUCTIVE IMPLANT
Applicant
Becker & Associates Consulting, Inc.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Applicant Contact CAMPBELL TUSKEY
Correspondent
Becker & Associates Consulting, Inc.
2001 Pennsylvania Ave. NW, Suite 950
Washington,  DC  20006
Correspondent Contact CAMPBELL TUSKEY
Regulation Number886.3320
Classification Product Code
HPZ  
Date Received01/16/2007
Decision Date 04/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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