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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Rotary Bone Cutting
510(k) Number K080939
Device Name SURGICAL HANDPIECES, MIKRO SAW HANDPIECES
Applicant
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLASER-STRASSE
BUERMOOS,  AT 5111
Applicant Contact GABRIELE WIENBECK
Correspondent
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLASER-STRASSE
BUERMOOS,  AT 5111
Correspondent Contact GABRIELE WIENBECK
Regulation Number872.4120
Classification Product Code
KMW  
Date Received04/03/2008
Decision Date 07/29/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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