Cleared Traditional

ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746

K973332 · Alcon Laboratories · Ophthalmic
Dec 1997
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K973332 is an FDA 510(k) clearance for the ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on December 2, 1997, 89 days after receiving the submission on September 4, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K973332 FDA.gov
FDA Decision Cleared SESE
Date Received September 04, 1997
Decision Date December 02, 1997
Days to Decision 89 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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