510(k) K003010
K003010 is an FDA 510(k) premarket notification submitted by United Pacific Co., Ltd. for the device "SPIRIT ACUPUNCTURE NEEDLE". The FDA issued a decision of Substantially Equivalent on October 19, 2000. The device falls under product code MQX (Needle, Acupuncture, Single Use), a Class II device regulated under 21 CFR 880.5580. United Pacific Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2000
- Date Received
- September 26, 2000
- 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