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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Barrier, Synthetic, Intraoral
510(k) Number K101956
Device Name STRAUMANN MEMBRAGEL
Applicant
Straumann USA (On Behalf of Institut Straumann Ag)
60 Minuteman Rd.
Andover,  MA  01810
Applicant Contact JANET C KAY
Correspondent
Straumann USA (On Behalf of Institut Straumann Ag)
60 Minuteman Rd.
Andover,  MA  01810
Correspondent Contact JANET C KAY
Regulation Number872.3930
Classification Product Code
NPK  
Date Received07/12/2010
Decision Date 12/16/2010
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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