LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE— 510(k) K853708

Name: FDA 510(k) clearance K853708
Creator: U.S. Food and Drug Administration
Published: 1986-02-14

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K853708 for LARYNGASCOPES, FORCEPS, MICRO SUCTION TUBE & REFLE, Substantially Equivalent on 1986-02-14. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code KAE
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1985-09-04
Decision date: 1986-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

Download summary PDF View on FDA.gov ↗

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K851795 — 41-250 TO 41-282 VARIOUS NASAL CUTTING FORCEPS1985-06-11
K833608 — GOLD ALLIGATOR FORCEPS1984-01-11
K833605 — CUPPED FORCEPS1984-01-03

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K903749 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U1990-10-31
K903750 — ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E1990-10-31
K900608 — SHEPPERD LUMBAR DISCECTOMY SYSTEM1990-10-22

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