BRIO ACUPUNCTURE NEEDLES


Device Classification Name

needle, acupuncture, single use

510(k) Number K072778
Device Name BRIO ACUPUNCTURE NEEDLES
Applicant
HELIO MEDICAL SUPPLIES, INC.
606 charcot ave.
san jose, 
CA 
95131

Applicant Contact yukuo hsu
Correspondent
HELIO MEDICAL SUPPLIES, INC.
606 charcot ave.
san jose, 
CA 
95131

Correspodent Contact yukuo hsu
Regulation Number 880.5580
Classification Product Code
MQX  
Date Received 09/28/2007
Decision Date 11/19/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

Type Traditional
Reviewed by Third Party No

Combination Product

No