510(k) K843136
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1984
- Date Received
- August 9, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hook, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type