510(k) K802249
K802249 is an FDA 510(k) premarket notification submitted by Progress Mankind Technology for the device "MICROLET FAMILY OF NEEDLE/DEPTH ELECT-". The FDA issued a decision of Substantially Equivalent on November 19, 1980. The device falls under product code GZL (Electrode, Depth), a Class II device regulated under 21 CFR 882.1330. Progress Mankind Technology has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 19, 1980
- Date Received
- September 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Depth
- Device Class
- Class II
- Regulation Number
- 882.1330
- Review Panel
- NE
- Submission Type