510(k) K960405
K960405 is an FDA 510(k) premarket notification submitted by Promex, Inc. for the device "SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on February 28, 1996. The device falls under product code MIA (Needle, Spinal, Short Term), a Class II device regulated under 21 CFR 868.5150. Promex, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1996
- Date Received
- January 29, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Spinal, Short Term
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type