JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE


Device Classification Name

needle, acupuncture, single use

510(k) Number K023054
Device Name JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE
Original Applicant
MANDALA HEALTH CARE, LLC
4320 spring valley rd.,
dallas, 
TX 
75244 -4352

Original Contact dashima dovchin
Regulation Number 880.5580
Classification Product Code
MQX  
Date Received 09/13/2002
Decision Date 11/13/2002
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