WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)


Device Classification Name

needle, acupuncture, single use

510(k) Number K111392
Device Name WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
Applicant
WOOJEON COMPANY
300 atwood
pittsburgh, 
PA 
15213

Applicant Contact peter chung
Correspondent
WOOJEON COMPANY
300 atwood
pittsburgh, 
PA 
15213

Correspodent Contact peter chung
Regulation Number 880.5580
Classification Product Code
MQX  
Date Received 05/18/2011
Decision Date 11/04/2011
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