SAFETYWAND DISPOSABLE HANDPIECE


Device Classification Name

syringe, cartridge

510(k) Number K023722
Device Name SAFETYWAND DISPOSABLE HANDPIECE
Original Applicant
SPINTECH, INC.
2000 m st. nw suite 700
washington, 
DC 
20036

Original Contact daniel j manelli
Regulation Number 872.6770
Classification Product Code
EJI  
Date Received 11/05/2002
Decision Date 09/02/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No