510(k) K931670

CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS by Carapace, Inc. — Product Code CAZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 25, 1994
Date Received: April 6, 1993
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 Carapace, Inc.

K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)
K931822 — CARAPACE PELVIC EXAM TRAYS (March 7, 1994)
K931729 — I.V. START KIT (February 22, 1994)
K931820 — CARAPACE STILLWATER BOWL SET (February 7, 1994)
K931669 — CARAPACE DEBRIDEMENT KITS (February 7, 1994)
K931760 — CARAPACE PACKING GAUZE TRAYS (February 4, 1994)
K932653 — SWISSTEK 2000(TM) CAST REMOVAL SYSTEM (January 28, 1994)
K931758 — CARAPACE WOUND DRESSING KITS & LACERATION TRAYS (January 26, 1994)
K931819 — CARAPACE SUTURE REMOVAL TRAYS (January 26, 1994)
K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

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