Cleared Traditional

K870278 - CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695
(FDA 510(k) Clearance)

Feb 1987
Decision
24d
Days
Class 2
Risk

K870278 is an FDA 510(k) clearance for the CONTACT LENS CASE W/POSTIVE HEAT INDI. MOD. #695. This device is classified as a Accessories, Soft Lens Products (Class II - Special Controls, product code LPN).

Submitted by Ryder Intl. Corp. (Arab, US). The FDA issued a Cleared decision on February 20, 1987, 24 days after receiving the submission on January 27, 1987.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.

Submission Details

510(k) Number K870278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1987
Decision Date February 20, 1987
Days to Decision 24 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

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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