510(k) K820526
K820526 is an FDA 510(k) premarket notification submitted by The Lebanon Corp. for the device "RELIEF VALVE-HONAN INTRAOC. PRESSURE". The FDA issued a decision of Substantially Equivalent on March 25, 1982. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610. The Lebanon Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 25, 1982
- Date Received
- February 26, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ocular Pressure
- Device Class
- Class II
- Regulation Number
- 886.4610
- Review Panel
- OP
- Submission Type