Cleared Traditional

K842781 - PERMALID PAK (FDA 510(k) Clearance)

Aug 1985
Decision
381d
Days
Risk

K842781 is an FDA 510(k) clearance for the PERMALID PAK..

Submitted by CooperVision, Inc. (Southampton, GB). The FDA issued a Cleared decision on August 1, 1985, 381 days after receiving the submission on July 16, 1984.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number K842781 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received July 16, 1984
Decision Date August 01, 1985
Days to Decision 381 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code
Device Class