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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Dental, Intraoral
510(k) Number K984508
Device Name SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
Applicant
W&H Dentalwerk Buermoos GmbH
53 Ignaz-Glaser-Strasse
A-5111
Buermoos,  AT 5111
Applicant Contact HERBERT TRASCHWANDTNER
Correspondent
W&H Dentalwerk Buermoos GmbH
53 Ignaz-Glaser-Strasse
A-5111
Buermoos,  AT 5111
Correspondent Contact HERBERT TRASCHWANDTNER
Regulation Number872.4130
Classification Product Code
DZA  
Date Received12/18/1998
Decision Date 06/25/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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