ROSEN'S STAPES NEEDLE EXPLORER— 510(k) K822277

Substantially Equivalent

Kelleher Corp.

FDA 510(k) clearance K822277 for ROSEN'S STAPES NEEDLE EXPLORER, Substantially Equivalent on 1982-08-25. Applicant: Kelleher Corp.. Device class: 1.

Clearance details

Applicant: Kelleher Corp.
Product code: Code KAK
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1982-07-29
Decision date: 1982-08-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

More clearances from Kelleher Corp.

K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH1983-01-28
K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET1983-01-28
K823083 — ELECTROSURGICAL UNIT1982-12-07
K822252 — ENT TREATMENT UNITS1982-11-22
K823111 — NYSTYMOGRAPH ACCESS1982-11-22

Recalls naming K822277

K-number listed on FDA's recall record

Z-0407-2013 — Vital Signs Disposable General Purpose 9 French Temperature Probe For monitoring of core temperatureClass II·Terminated·Vital Signs Colorado Inc.·20120817

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K822277.

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