REUSABLE SURGICAL KERATOSCOPE— 510(k) K864639

Name: FDA 510(k) clearance K864639
Creator: U.S. Food and Drug Administration
Published: 1986-12-29

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K864639 for REUSABLE SURGICAL KERATOSCOPE, Substantially Equivalent on 1986-12-29. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code HLR
Device class: Class 1
Regulation: 21 CFR 886.1350
Advisory panel: Ophthalmic
Date received: 1986-11-26
Decision date: 1986-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HLR

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K901553 — SURG-K SURGICAL KERATOMETER1990-07-20
K882902 — QRK 100, QUALITATIVE RING KERATOSCOPE1988-08-04
K882618 — JEDMED/POLACK KERATOSCOPE HS/SL1988-07-13
K854054 — PLACIDO DISC1985-12-27
K830008 — KARICKHOFF KERATOSCOPE1983-01-26

More clearances from Jedmed Instrument Co.

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K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM2014-02-21
K021750 — LID CHAIN EYELID WEIGHTS2003-01-27
K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE1995-11-13
K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE)1995-09-15
K950925 — JEDMED LARYNGEAL SCOPE1995-08-11

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