510(k) K811311
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 1981
- Date Received
- May 11, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lamp, Surgical, Incandescent
- Device Class
- Class II
- Regulation Number
- 878.4580
- Review Panel
- SU
- Submission Type