MINIJECT


Device Classification Name

syringe, cartridge

510(k) Number K991888
Device Name MINIJECT
Applicant
SPARTAN ULTRASONICS, INC.
1663 fenton business park ct.
fenton, 
MO 
63026

Applicant Contact aldo eagle
Correspondent
SPARTAN ULTRASONICS, INC.
1663 fenton business park ct.
fenton, 
MO 
63026

Correspodent Contact aldo eagle
Regulation Number 872.6770
Classification Product Code
EJI  
Date Received 06/02/1999
Decision Date 08/25/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No