Cleared Traditional

K810937 - ANIS IRRIGATING SPATULA
(FDA 510(k) Clearance)

K810937 · American V. Mueller · Ophthalmic device

May 1981

Decision

38d

Days

Class 1

Risk

K810937 is an FDA 510(k) clearance for the ANIS IRRIGATING SPATULA. This device is classified as a Spatula, Ophthalmic (Class I - General Controls, product code HND).

Submitted by American V. Mueller (Mchenry, US). The FDA issued a Cleared decision on May 15, 1981, 38 days after receiving the submission on April 7, 1981.

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

Submission Details

510(k) Number	K810937 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 1981
Decision Date	May 15, 1981
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—