510(k) K802524
K802524 is an FDA 510(k) premarket notification submitted by Midshore Welding Corp. for the device "SURGICAL HAMMERS". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code FZY (Hammer, Surgical), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 16, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hammer, Surgical
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type