510(k) K994059

CLA KIT (CONTINUOUS LOCAL ANESTHESIA), MODEL 551-17, 551-10, 551-07 by Hdc Corp. — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 13, 2000
Date Received: November 29, 1999
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 Hdc Corp.

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K052471 — HDC SPIDER SCREW (December 23, 2005)
K023342 — NEURO-TRACE III KIT, NEURO-TRACE III REGIONAL BLOCK CABLE, NEURO-TRACE III NERVE (March 2, 2004)
K033853 — MODIFICATION TO V-CATH POLY PICC (January 14, 2004)
K032404 — SELDINGER SAFETY NEEDLE INTRODUCER (September 10, 2003)
K022752 — PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09, 561-1 (September 9, 2003)
K022099 — SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390- (September 20, 2002)
K010425 — EPIDURAL CATHETER WITH CONNECTOR (AND ACCESSORY) (March 15, 2001)

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