Cleared Traditional

K842814 - PERMALID LINER PAK (FDA 510(k) Clearance)

Aug 1985
Decision
379d
Days
Risk

K842814 is an FDA 510(k) clearance for the PERMALID LINER PAK..

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1985, 379 days after receiving the submission on July 18, 1984.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K842814 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 18, 1984
Decision Date August 01, 1985
Days to Decision 379 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class