STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS— 510(k) K961524

Name: FDA 510(k) clearance K961524
Creator: U.S. Food and Drug Administration
Published: 1996-05-16

Substantially Equivalent

Sterilab, Inc.

FDA 510(k) clearance K961524 for STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS, Substantially Equivalent on 1996-05-16. Applicant: Sterilab, Inc.. Device class: 1.

Clearance details

Applicant: Sterilab, Inc.
Product code: Code HNY
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1996-04-22
Decision date: 1996-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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K874975 — PRISMA DISPOSABLE SHARP ANGLED IRRIGAT. CYSTOTOME1988-04-13
K874976 — PRISMA DISPOS. DOUBLE SHARP IRRIGATING CYSTOTOME1988-04-13
K874983 — PRISMA DISPOSABLE ANGLED IRRIGATING CYSTOTOME1988-04-13
K874993 — PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME1988-04-13

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