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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K041070
Device Name STRAUMANN TEMPORARY COPING
Applicant
THE STRAUMANN CO.
RESERVOIR PL. 1601 TRAPELO RD.
WALTHAM,  MA  02451
Applicant Contact LINDA JALBERT
Correspondent
THE STRAUMANN CO.
RESERVOIR PL. 1601 TRAPELO RD.
WALTHAM,  MA  02451
Correspondent Contact LINDA JALBERT
Regulation Number872.3630
Classification Product Code
NHA  
Date Received04/26/2004
Decision Date 07/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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