SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS


Device Classification Name

wrap, sterilization

510(k) Number K112591
Device Name SAFE SECURE STERILIZATION POUNCH WITH STEAM AND ETHYLENE OXIDE PROCESS INDICATORS
Applicant
SAFE SECURE PACKAGING CO., LTD
chengguang industrial park,
no.4 kukeng po new village
shenzhen, guangdon, 

CN

5181100

Applicant Contact garfield wang
Regulation Number 880.6850
Classification Product Code
FRG  
Date Received 09/07/2011
Decision Date 02/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No