510(k) K900282
K900282 is an FDA 510(k) premarket notification submitted by Macbrud Corp. Medical Div. for the device "NEEDLE-SHIELD". The FDA issued a decision of Substantially Equivalent on February 28, 1990. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Macbrud Corp. Medical Div. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1990
- Date Received
- January 21, 1990
- 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