510(k) K060563

EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV by Pajunk GmbH — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 2, 2006
Date Received: February 8, 2006
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.

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K043130 — MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS (December 21, 2004)
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K040965 — PAJUNK TUOHY NEEDLES, QUINCKE NEEDLES, CHIBA NEEDLES & CRAWFORD NEEDLES (September 7, 2004)
K033018 — STIMULONG PLUS CATHETER SET MODEL, VARIOUS (May 5, 2004)
K033249 — PAJUNK MODULAR HANDLE INSTRUMENTS (March 5, 2004)
K023218 — MODIFICATION TO PLEXOLONG SETS (March 24, 2003)

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