510(k) K880812
K880812 is an FDA 510(k) premarket notification submitted by T. Korossurgical Instruments Corp. for the device "SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on March 11, 1988. The device falls under product code GDM (Needle, Aspiration And Injection, Reusable), a Class I device regulated under 21 CFR 878.4800. T. Korossurgical Instruments Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1988
- Date Received
- February 26, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Aspiration And Injection, Reusable
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type