KARICKHOFF KERATOSCOPE— 510(k) K830008

Substantially Equivalent

Surgidev Corp.

FDA 510(k) clearance K830008 for KARICKHOFF KERATOSCOPE, Substantially Equivalent on 1983-01-26. Applicant: Surgidev Corp.. Device class: 1.

Clearance details

Applicant: Surgidev Corp.
Product code: Code HLR
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1983-01-03
Decision date: 1983-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLR

K901553 — SURG-K SURGICAL KERATOMETER1990-07-20
K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE1988-08-04
K882618 — JEDMED/POLACK KERATOSCOPE HS/SL1988-07-13
K864639 — REUSABLE SURGICAL KERATOSCOPE1986-12-29
K854054 — PLACIDO DISC1985-12-27

More clearances from Surgidev Corp.

K850729 — ACUFLO VOLUMETRIC CONTROLLED DELIVERY SYS 20001985-04-09
K831829 — KARICKHOFF FLYING CORPUSCLE VIEWER1983-10-19
K831975 — LEADING EDGE OPHTHALMIC KNIFE1983-08-31

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