510(k) K840287

BRACHIAL PLEXUS ANESTHESIA TRAY by Burron Medical Products, Inc. — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 23, 1984
Date Received: January 24, 1984
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Anesthesia Conduction Kit
Device Class: Class II
Regulation Number: 868.5140
Review Panel: AN
Submission Type

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Burron Medical Products, Inc.

K870403 — CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE (May 1, 1987)
K862412 — INTESTOPLANT (November 13, 1986)
K861479 — CAVAFIX, CENTRAL VENOUS CATHETER KIT (July 1, 1986)
K860126 — STIMUPLEX, NERVE STIMULATOR (February 28, 1986)
K851293 — IMPLANTOFIX (January 9, 1986)
K841428 — JEJUNOSTOMY SET FOR TUBE FEEDING (July 9, 1984)
K834299 — LONG TERM CENTRAL VENOUS ACCESS CATH (May 1, 1984)
K834383 — DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT (May 1, 1984)
K834473 — MULTI-LUMEN CENTRAL VENOUS CATH. KIT (April 30, 1984)
K840179 — CONTINUOUS EPIDURAL ANESTHES. TRAY (February 24, 1984)

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