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510(k) K852112

SURGICAL STARTER KIT by Devon Industries, Inc.

K852112 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "SURGICAL STARTER KIT". The FDA issued a decision of Substantially Equivalent on June 12, 1985. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1985
Date Received
May 15, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Devon Industries, Inc.

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • 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)

FDA data resources