510(k) K905427
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 1991
- Date Received
- December 4, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plug, Punctum
- Device Class
- Class U
- Regulation Number
- Review Panel
- OP
- Submission Type