510(k) K823693
K823693 is an FDA 510(k) premarket notification submitted by Ocean Medical Products, Ltd. for the device "MYELOGRAPHY NEEDLE". The FDA issued a decision of Substantially Equivalent on February 7, 1983. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ocean Medical Products, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 7, 1983
- Date Received
- December 8, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type