510(k) K853604
K853604 is an FDA 510(k) premarket notification submitted by Today'S Machining & Design, Inc. for the device "ACE-KYLE DYE INJECTION NEEDLE P/N 14082". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Today'S Machining & Design, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1985
- Date Received
- August 28, 1985
- 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