510(k) K862523
K862523 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "MAN SURG INSTR/ACCESS DUMBACH TITAN MESH IMPL SYS". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code EKW (Broach, Endodontic), a Class I device regulated under 21 CFR 872.4565. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 1986
- Date Received
- July 2, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Broach, Endodontic
- Device Class
- Class I
- Regulation Number
- 872.4565
- Review Panel
- DE
- Submission Type