• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Handpiece, Contra- And Right-Angle Attachment, Dental
510(k) Number K011061
Device Name SURGICAL CONTRA-ANGEL HANDPIECES TYPES WS-56E,WS-75E/KM,WS-92 E/3,SURGICAL STRAIGHT HANDPIECES TYPES, S-9, S-10, S-11
Applicant
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLAZER-STRASSE
BUERMOOS,  AT 5111
Applicant Contact HERBERT TRASCHWANDTNER
Correspondent
W & H DENTALWERK BUERMOOS GMBH
53 IGNAZ-GLAZER-STRASSE
BUERMOOS,  AT 5111
Correspondent Contact HERBERT TRASCHWANDTNER
Regulation Number872.4200
Classification Product Code
EGS  
Date Received04/06/2001
Decision Date 06/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-