MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K073705
Device Name MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE
Applicant
SHANDONG QIAOPAI GROUP CO., LTD
no.13,qinghe road,gaoqing county
zibo, 

CN

256300

Applicant Contact mark job
Regulation Number 880.5570
Classification Product Code
FMI  
Subsequent Product Code
FOZ  
Date Received 12/31/2007
Decision Date 03/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party Yes

Combination Product

No