510(k) K021750
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 2003
- Date Received
- May 28, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Weights, Eyelid, External
- Device Class
- Class II
- Regulation Number
- 886.5700
- Review Panel
- OP
- Submission Type
Gravity assisted treatment of lagophthalmos (incomplete eyelid closure)