Cleared Traditional

BAUSCH & LOMB WETTING AND SOAKING SOLUTION

K980133 · Polymer Technology Corp. · Ophthalmic
Mar 1998
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K980133 is an FDA 510(k) clearance for the BAUSCH & LOMB WETTING AND SOAKING SOLUTION, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on March 11, 1998, 55 days after receiving the submission on January 15, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K980133 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1998
Decision Date March 11, 1998
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code LPN — Accessories, Soft Lens Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5928

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