DISPOSABLE THERMOMETER COVERS AND SHEATHS


Device Classification Name

thermometer, electronic, clinical

510(k) Number K112289
Device Name DISPOSABLE THERMOMETER COVERS AND SHEATHS
Applicant
KANG ZE INDUSTRIAL CO. LIMITED
rm 1706 yuesha bldg
no 128 songle rd
songjiang area, shanghai, 

CN

201600

Applicant Contact doris dong
Correspondent
KANG ZE INDUSTRIAL CO. LIMITED
rm 1706 yuesha bldg
no 128 songle rd
songjiang area, shanghai, 

CN

201600

Correspodent Contact doris dong
Regulation Number 880.2910
Classification Product Code
FLL  
Subsequent Product Code
FLK  
Date Received 08/09/2011
Decision Date 12/16/2011
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

No