BINOCULAR LOUPE— 510(k) K830878

Substantially Equivalent

Almore Intl., Inc.

FDA 510(k) clearance K830878 for BINOCULAR LOUPE, Substantially Equivalent on 1983-04-06. Applicant: Almore Intl., Inc.. Device class: 1.

Clearance details

Applicant: Almore Intl., Inc.
Product code: Code HJH
Device class: Class 1
Regulation: 21 CFR 886.5120
Advisory panel: Ophthalmic
Date received: 1983-03-18
Decision date: 1983-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HJH

K874845 — MALIS SURGICAL LOUPES1987-12-23
K863983 — EXETER OPERATING LOUPE1986-11-10

More clearances from Almore Intl., Inc.

K862851 — ALMORE FACE MASK1986-08-12
K854692 — MONARCH II BLEACHING INSTRUMENT1986-05-12
K854696 — OP II VISIBLE LIGHT CURING SYSTEM1986-03-26
K854690 — DIAMONDS BURS-COMPOSIT FINISHING1986-03-25
K854691 — DIAMOND BURS-HANDPIECE1986-03-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.