510(k) K033597
K033597 is an FDA 510(k) premarket notification submitted by Advanced Technology Research (A.T.R.) S.R.L. for the device "ATR 5000, LC 5000, IMPLANT SYSTEM". The FDA issued a decision of Substantially Equivalent on November 25, 2003. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. Advanced Technology Research (A.T.R.) S.R.L. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 2003
- Date Received
- November 14, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Handpiece, Direct Drive, Ac-Powered
- Device Class
- Class I
- Regulation Number
- 872.4200
- Review Panel
- DE
- Submission Type