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510(k) K931722

CARAPACE LABOR AND DELIVERY SETS by Carapace, Inc. — Product Code MLS

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 23, 1994
Date Received
April 7, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Labor And Delivery Kit
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
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.

  • 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)
  • K931670 — CARAPACE EPIDURAL BLOCK & SPINAL MYELOGRAM TRAYS (January 25, 1994)
  • K931759 — CARAPACE STERILE GAUZE TRAYS (January 25, 1994)

Other clearances for product code MLS

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • K960243 — CPR C-SECTION DELIVERY PACK (May 23, 1996)
  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K932216 — C-SECTION, LABOR & DELIVERY TRAYS (PACKS) (April 19, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 1994)