Cleared Traditional

K760185 - SCISSORS, MICRO IRIS STRAIGHT (FDA 510(k) Clearance)

Aug 1976
Decision
29d
Days
Class 1
Risk

K760185 is an FDA 510(k) clearance for the SCISSORS, MICRO IRIS STRAIGHT. This device is classified as a Scissors, Ophthalmic (Class I - General Controls, product code HNF).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 4, 1976, 29 days after receiving the submission on July 6, 1976.

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

Submission Details

510(k) Number K760185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1976
Decision Date August 04, 1976
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary

Device Classification

Product Code HNF — Scissors, Ophthalmic
Device Class Class I - General Controls
CFR Regulation 21 CFR 886.4350