BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,


Device Classification Name

catheter, urethral

510(k) Number K111405
Device Name BEVER UNOCATED / COATED, PAEDIATRIC / MALE / FEMALE NELATON-TIP / TIEMANN-TIP INTERMITTENT CATHETER,
Applicant
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
no. 8-1, longquan road
cangqian town, yuhang district
hangzhou, zhejiang, 

CN

311121

Applicant Contact allyson zhou
Correspondent
HANGZHOU BEVER MEDICAL DEVICES CO., LTD.
no. 8-1, longquan road
cangqian town, yuhang district
hangzhou, zhejiang, 

CN

311121

Correspodent Contact allyson zhou
Regulation Number 876.5130
Classification Product Code
GBM  
Date Received 05/19/2011
Decision Date 02/13/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No