510(k) K895432
K895432 is an FDA 510(k) premarket notification submitted by Ausmedics Pty , Ltd. for the device "SAFE-T-CAP". The FDA issued a decision of Substantially Equivalent on November 3, 1989. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Ausmedics Pty , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1989
- Date Received
- September 8, 1989
- 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