VAN DELLEN IRRIGATING CYSTOTOME— 510(k) K873163

Name: FDA 510(k) clearance K873163
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

Van Dellen, Ltd.

FDA 510(k) clearance K873163 for VAN DELLEN IRRIGATING CYSTOTOME, Substantially Equivalent on 1987-09-04. Applicant: Van Dellen, Ltd.. Device class: 1.

Clearance details

Applicant: Van Dellen, Ltd.
Product code: Code HNY
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1987-08-11
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tucson, AZ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HNY

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K961524 — STERILAB CANNULAS, STERILAB CYSTOTMES, STERILAB NEEDLES AND STERILAB LENS MANIPULATORS1996-05-16
K880345 — CYSTOTOMES/KNIFES1988-05-03
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

More clearances from Van Dellen, Ltd.

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K873465 — VAN DELLEN BACTERIA FILTER1988-01-20
K873463 — VAN DELLEN ASPIRATING TUBING1987-11-23
K873464 — VAN DELLEN CANNULA1987-11-23
K873462 — VAN DELLEN ASPIRATOR1987-09-25
K873162 — VAN DELLEN RETROBULBAR NEEDLE1987-09-04

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