510(k) K831285
K831285 is an FDA 510(k) premarket notification submitted by Richard R. Anthony, M.D. for the device "SURGICAL/LID MARGIN COVER & EYELASH-". The FDA issued a decision of Substantially Equivalent on June 3, 1983. The device falls under product code HOD (Clamp, Eyelid, Ophthalmic), a Class I device regulated under 21 CFR 886.4350.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1983
- Date Received
- April 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Eyelid, Ophthalmic
- Device Class
- Class I
- Regulation Number
- 886.4350
- Review Panel
- OP
- Submission Type