COMPACT AUTO-SAFETY INJECTOR (CASI)


Device Classification Name

introducer, syringe needle

510(k) Number K073476
Device Name COMPACT AUTO-SAFETY INJECTOR (CASI)
Applicant
MEDICAL HOUSE (ASI) LIMITED
199, newhall rd.
sheffield, 

GB

s9 2qj

Applicant Contact rose y guang
Correspondent
MEDICAL HOUSE (ASI) LIMITED
199, newhall rd.
sheffield, 

GB

s9 2qj

Correspodent Contact rose y guang
Regulation Number 880.6920
Classification Product Code
KZH  
Date Received 12/10/2007
Decision Date 03/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

Yes