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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Breast, External, Used With Adhesive
510(k) Number K990458
Device Name STRAUMANN EXTRAORAL IMPLANT SYSTEM
Applicant
Straumann USA
Reservoir Pl.,
1601 Trapelo Rd.
Waltham,  MA  02154
Applicant Contact LINDA JALBERT
Correspondent
Straumann USA
Reservoir Pl.,
1601 Trapelo Rd.
Waltham,  MA  02154
Correspondent Contact LINDA JALBERT
Regulation Number878.3800
Classification Product Code
KCZ  
Date Received02/12/1999
Decision Date 04/16/1999
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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