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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact YI-FEN CHANG
Regulation Number880.5580
Classification Product Code
MQX  
Date Received04/29/1999
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
Predetermined Change
Control Plan Authorized		 No
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