CATEGORY 6 OPTHALMIC DEVICES— 510(k) K840310

Name: FDA 510(k) clearance K840310
Creator: U.S. Food and Drug Administration
Published: 1984-03-16

Substantially Equivalent

Imm Enterprises , Ltd.

FDA 510(k) clearance K840310 for CATEGORY 6 OPTHALMIC DEVICES, Substantially Equivalent on 1984-03-16. Applicant: Imm Enterprises , Ltd.. Device class: 1.

Clearance details

Applicant: Imm Enterprises , Ltd.
Product code: Code HOB
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1984-01-24
Decision date: 1984-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K840101 — EYE SURGERY INSTRUMENT1984-03-16
K780851 — CHARLES ENDOCOAGULATOR ACCESSORY FOR ARC1978-06-30

More clearances from Imm Enterprises , Ltd.

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K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES1984-05-09
K841386 — KOLLMANN URETHRAL DILATOR1984-05-09
K841387 — WESTON RECTAL SNARE1984-05-09
K840304 — CATEGORY 17-MICROBIOLOGY DEVICES1984-05-01
K840305 — CATEGORY 1 CIRCULATORY SYSTEM DEVICE1984-04-23

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