510(k) K800418
K800418 is an FDA 510(k) premarket notification submitted by A.D.T. Lab Industries for the device "ADT DISPOSABLE THIN NEEDLE ASPIRATION". The FDA issued a decision of Substantially Equivalent on April 28, 1980. The device falls under product code FSM (Tray, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. A.D.T. Lab Industries has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 28, 1980
- Date Received
- February 26, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tray, Surgical, Instrument
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type