510(k) K024207

VINCO BRAND ACUPUNCTURE NEEDLE by Helio Medical Supplies, Inc. — Product Code MQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 2003
Date Received
December 20, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Acupuncture, Single Use
Device Class
Class II
Regulation Number
880.5580
Review Panel
HO
Submission Type