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COMPLETE BRAND MULTI-PURPOSE SOLUTION

K003252 Class II Traditional
Decision Date
2001-02-21
Sponsor / Applicant
Allergan, Inc.

Technical Specification

510(k) Submission ID K003252
Product Code LPN
Medical Specialty / Panel Ophthalmic
Regulation Citation 21 CFR 886.5928
Decision Date 2001-02-21
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

COMPLETE BRAND MULTI-PURPOSE SOLUTION received FDA 510(k) clearance under submission number K003252, sponsored by Allergan, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-02-21.

Classification & Regulation

This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.