LOW-POWER BINOCULAR LOUPE— 510(k) K875124

Name: FDA 510(k) clearance K875124
Creator: U.S. Food and Drug Administration
Published: 1988-02-19

Substantially Equivalent

Seiler Instrument & Mfg. Co., Inc.

FDA 510(k) clearance K875124 for LOW-POWER BINOCULAR LOUPE, Substantially Equivalent on 1988-02-19. Applicant: Seiler Instrument & Mfg. Co., Inc.. Device class: 1.

Clearance details

Applicant: Seiler Instrument & Mfg. Co., Inc.
Product code: Code HOH
Device class: Class 1
Regulation: 21 CFR 886.4770
Advisory panel: Ophthalmic
Date received: 1987-12-15
Decision date: 1988-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HOH

view all

K934494 — SURGITEL1994-01-25
K810817 — EXETER OPERATING LOUPE1981-04-23

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