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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K011698
Device Name STRAUMANN GBR SYSTEM
Applicant
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
Institut Straumann AG
Reservoir Pl. 1601 Trapelo Rd.
Waltham,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.4760
Classification Product Code
JEY  
Subsequent Product Code
DZL  
Date Received06/01/2001
Decision Date 08/23/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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