510(k) K920305
K920305 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "PHARMASEAL CLEAR HUB SPINAL NEEDLE". The FDA issued a decision of Substantially Equivalent on Jan 27, 1993. The device falls under product code BSP (Needle, Conduction, Anesthetic (W/Wo Introducer)), a Class II device regulated under 21 CFR 868.5150. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 27, 1993
- Date Received
- Jan 22, 1992
- 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
- 510(k)