Cleared Traditional

K760848 - FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU (FDA 510(k) Clearance)

Nov 1976
Decision
18d
Days
Class 1
Risk

K760848 is an FDA 510(k) clearance for the FELDSTEIN BLEPHAROPLASTY CLIP RECTANGU. This device is classified as a Specula, Ophthalmic (Class I - General Controls, product code HNC).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on November 2, 1976, 18 days after receiving the submission on October 15, 1976.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4350.

Submission Details

510(k) Number K760848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1976
Decision Date November 02, 1976
Days to Decision 18 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HNC — Specula, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.4350