← Product Code [MRC](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC) · K011456

# DELTA PLUS MULTIACTION SOLUTION FOR RIGID GAS PERMEABLE CONTACT LENSES (K011456)

_Sauflon Pharmaceuticals, Ltd. · MRC · Jul 17, 2001 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K011456

## Device Facts

- **Applicant:** Sauflon Pharmaceuticals, Ltd.
- **Product Code:** [MRC](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC.md)
- **Decision Date:** Jul 17, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5918
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A rigid gas permeable contact lens care product is a device intended for use in the cleaning, conditioning, rinsing, lubricating/rewetting, or storing of a rigid gas permeable contact lens. This includes all solutions and tablets used together with rigid gas permeable contact lenses.

## Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K011456](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/MRC/K011456)

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