510(k) K822255

RIGID SUCTION TIPS by Kelleher Corp. — Product Code KTR

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 25, 1982
Date Received: July 29, 1982
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tube, Aspirating, Bronchoscope, Rigid
Device Class: Class II
Regulation Number: 874.4680
Review Panel: EN
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Kelleher Corp.

K822618 — EMERGENCY TRACHEOSTOMY INSTRUMENT SET (January 28, 1983)
K822268 — NAGASHIMA NS-III ELECTRONYSTAGMOGRAPH (January 28, 1983)
K823083 — ELECTROSURGICAL UNIT (December 7, 1982)
K822252 — ENT TREATMENT UNITS (November 22, 1982)
K823111 — NYSTYMOGRAPH ACCESS (November 22, 1982)
K822272 — HEAD MIRRORS W/HEAD LAMPS & HEAD BANDS (November 10, 1982)
K822017 — TYMPANOSTOMY TUBES & VARIOUS TYPES (October 27, 1982)
K822257 — VARIOUS TYPES OF LIGHT SOURCE HANDLES (October 26, 1982)
K822259 — LARYNGEAL SPATULAS (October 22, 1982)
K822004 — FACE SHIELDS (October 20, 1982)

510(k) K822255

Clearance Details

Device Classification

Other clearances by Kelleher Corp.

Other clearances for product code KTR