ACUMASTER BRAND ACUPUNCTURE NEEDLE


Device Classification Name

needle, acupuncture, single use

510(k) Number K991508
Device Name ACUMASTER BRAND ACUPUNCTURE NEEDLE
Applicant
HELIO MEDICAL SUPPLIES, INC.
2080a walsh ave.
santa clara, 
CA 
95050

Applicant Contact yi-fen chang
Correspondent
HELIO MEDICAL SUPPLIES, INC.
2080a walsh ave.
santa clara, 
CA 
95050

Correspodent Contact yi-fen chang
Regulation Number 880.5580
Classification Product Code
MQX  
Date Received 04/29/1999
Decision Date 08/27/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No