510(k) K852032
K852032 is an FDA 510(k) premarket notification submitted by Visitec Co. for the device "OCULAR PRESSURE REDUCER (MCCANNEL)". The FDA issued a decision of Substantially Equivalent on August 12, 1985. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610. Visitec Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1985
- Date Received
- May 9, 1985
- 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