510(k) K896219
K896219 is an FDA 510(k) premarket notification submitted by Ausmedics Pty , Ltd. for the device "SAFE-T-CAP NEEDLE COVER". The FDA issued a decision of Substantially Equivalent on January 22, 1990. The device falls under product code DZM (Needle, Dental), a Class I device regulated under 21 CFR 872.4730. Ausmedics Pty , Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 22, 1990
- Date Received
- October 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Dental
- Device Class
- Class I
- Regulation Number
- 872.4730
- Review Panel
- DE
- Submission Type