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510(k) K961993

BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) by Devon Industries, Inc. — Product Code MLS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 1996
Date Received
May 21, 1996
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 Devon Industries, Inc.

  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE (July 10, 1995)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K944114 — PHLEBOTOMY UNIT SHARPS A GATOR (December 2, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K932998 — EASY-ON (August 18, 1993)
  • K912824 — DEVON SPONGE COUNTER BAGS (August 26, 1991)
  • K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER (September 7, 1989)
  • K892660 — HIBERNATION KIT (August 15, 1989)

Other clearances for product code MLS

  • 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)
  • K931722 — CARAPACE LABOR AND DELIVERY SETS (March 23, 1994)