510(k) K840204

WHITE OCULAR PRESSURE RELIEF DEVICE by Precision-Cosmet Co., Inc. — Product Code KYF

K840204 is an FDA 510(k) premarket notification submitted by Precision-Cosmet Co., Inc. for the device "WHITE OCULAR PRESSURE RELIEF DEVICE". The FDA issued a decision of Substantially Equivalent on February 15, 1985. The device falls under product code KYF (Implant, Eye Valve), a Class II device regulated under 21 CFR 886.3920. Precision-Cosmet Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1985
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Eye Valve
Device Class
Class II
Regulation Number
886.3920
Review Panel
OP
Submission Type