510(k) K852032

OCULAR PRESSURE REDUCER (MCCANNEL) by Visitec Co. — Product Code LCC

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