510(k) K033409
K033409 is an FDA 510(k) premarket notification submitted by Gettig Pharmaceutical Instrument Co. for the device "AMERSHAM HEALTH NEEDLE-GUARD". The FDA issued a decision of Substantially Equivalent on January 21, 2004. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Gettig Pharmaceutical Instrument Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2004
- Date Received
- October 24, 2003
- 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