510(k) K954706

KENDALL BLUNT TUOHY EPIDURAL NEEDLE by Kendall Healthcare Products Co. Div.Of Tyco Health — Product Code CAZ

Clearance Details

Decision: SESD (Substantially Equivalent (with conditions))
Decision Date: May 30, 1996
Date Received: October 12, 1995
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 Kendall Healthcare Products Co. Div.Of Tyco Health

K973763 — KENDALL CURITY IODOFORM PACKING STRIP (December 31, 1997)
K973511 — KENDALL CURITY PETROLATUM GAUZE (December 16, 1997)
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) (December 15, 1997)
K973619 — KENDALL CURITY NON-ADHERING DRESSING (December 10, 1997)
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING (December 4, 1997)
K973546 — KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER (November 7, 1997)
K970266 — KENDALL HYDROPHILIC POWDER WOUND DRESSING (April 23, 1997)
K963446 — KENDALL DUAL LUMEN CATHETER (March 18, 1997)
K964899 — KENDALL CURITY URETERAL CATHETER (February 7, 1997)
K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)

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