JEDMED/POLACK KERATOSCOPE HS/SL— 510(k) K882618

Substantially Equivalent

Gamut Ent.

FDA 510(k) clearance K882618 for JEDMED/POLACK KERATOSCOPE HS/SL, Substantially Equivalent on 1988-07-13. Applicant: Gamut Ent.. Device class: 1.

Clearance details

Applicant: Gamut Ent.
Product code: Code HLR
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1988-06-24
Decision date: 1988-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Snellville, GA, 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
K864639 — REUSABLE SURGICAL KERATOSCOPE1986-12-29
K854054 — PLACIDO DISC1985-12-27
K830008 — KARICKHOFF KERATOSCOPE1983-01-26

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