Cleared Traditional

K792383 - KELMAN DIPSTICK
(FDA 510(k) Clearance)

K792383 · V. Mueller O.V. Baxter Healthcare Corp. · Ophthalmic device

Dec 1979

Decision

15d

Days

Class 1

Risk

K792383 is an FDA 510(k) clearance for the KELMAN DIPSTICK. This device is classified as a Caliper, Ophthalmic (Class I - General Controls, product code HOE).

Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 11, 1979, 15 days after receiving the submission on November 26, 1979.

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

Submission Details

510(k) Number	K792383 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 26, 1979
Decision Date	December 11, 1979
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—