SURGICAL HANDPIECES, MIKRO SAW HANDPIECES


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

Correspodent Contact gabriele wienbeck
Regulation Number 872.4120
Classification Product Code
KMW  
Date Received 04/03/2008
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