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510(k) K873744

LEUKOCLIP(R) by Beiersdorf, Inc. — Product Code FZQ

K873744 is an FDA 510(k) premarket notification submitted by Beiersdorf, Inc. for the device "LEUKOCLIP(R)". The FDA issued a decision of Substantially Equivalent on September 30, 1987. The device falls under product code FZQ (Clip, Removable (Skin)), a Class I device regulated under 21 CFR 878.4320. Beiersdorf, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 1987
Date Received
September 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Removable (Skin)
Device Class
Class I
Regulation Number
878.4320
Review Panel
SU
Submission Type

Other clearances by Beiersdorf, Inc.

  • K090921 — ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, (December 18, 2009)
  • K032463 — CURAD SILVER BANDAGE (February 10, 2004)
  • K032462 — CURAD SILVER ACTIVE GEL BANDAGE (February 10, 2004)
  • K024057 — CURAD SCAR THERAPY (June 18, 2003)
  • K022645 — CURAD (November 5, 2002)
  • K952526 — CUTINOVA CAVITY (August 14, 1995)
  • K943363 — CUTIPLAST STERIL (March 15, 1995)
  • K944581 — CUTINOVA THIN WOUND DRESSING (December 2, 1994)
  • K935630 — NORTA (October 7, 1994)
  • K940378 — COVERLET ADHESIVE DRESSING (July 29, 1994)

Other clearances for product code FZQ

  • K884783 — RANEY CLIP (November 30, 1988)
  • K830704 — ONE TIME DISPOSABLE SKIN STAPLER (April 12, 1983)
  • K830768 — DISPOSABLE SKIN STAPLER (April 12, 1983)
  • K822963 — SURGICAL PRODUCTS, SKIN STAPLE REMOVER (November 8, 1982)
  • K822145 — COMPLETE (October 22, 1982)

FDA data resources