WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR


definition

Device Classification Name

unit, electrosurgical, and accessories, dental

510(k) Number K000768
Device Name WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Original Applicant
WALLACH SURGICAL DEVICES, INC.
235 edison rd.
orange, 
CT 
06477

Original Contact michael malis
Regulation Number 872.4920
Classification Product Code
EKZ  
Date Received 03/09/2000
Decision Date 04/11/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

Type Traditional
Reviewed by Third Party No

Combination Product

No