510(k) K990100
K990100 is an FDA 510(k) premarket notification submitted by Te ME NA S.A.R.L. for the device "POLYMEDIC UPA NERVE STIMULATION NEEDLE; POLYMEDIC UPC NERVE STIMULATION NEEDLE". The FDA issued a decision of Substantially Equivalent on August 2, 2000. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350. Te ME NA S.A.R.L. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 2, 2000
- Date Received
- January 4, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Needle
- Device Class
- Class II
- Regulation Number
- 882.1350
- Review Panel
- NE
- Submission Type