510(k) K780852
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 3, 1978
- Date Received
- May 22, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Vitreous Aspiration And Cutting, Battery-Powered
- Device Class
- Class II
- Regulation Number
- 886.4150
- Review Panel
- OP
- Submission Type