510(k) K823692
K823692 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on January 7, 1983. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1983
- Date Received
- December 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Conduction, Anesthetic (W/Wo Introducer)
- Device Class
- Class II
- Regulation Number
- 868.5150
- Review Panel
- AN
- Submission Type