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510(k) K862726

DISPOSABLE SHOE COVERS AND NURSES CAPS by Abco Dealers, Inc. — Product Code FXP

K862726 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "DISPOSABLE SHOE COVERS AND NURSES CAPS". The FDA issued a decision of Substantially Equivalent on August 1, 1986. The device falls under product code FXP (Cover, Shoe, Operating-Room), a Class I device regulated under 21 CFR 878.4040. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 1986
Date Received
July 18, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cover, Shoe, Operating-Room
Device Class
Class I
Regulation Number
878.4040
Review Panel
HO
Submission Type

Other clearances by Abco Dealers, Inc.

  • K905025 — DIGITAL THERMOMETER KITS (February 7, 1991)
  • K882304 — DIGITAL THERMOMETER SHEATHS (ORAL AND RECTAL) (July 12, 1988)
  • K880892 — BLOOD COLLECTING NEEDLE AND HOLDERS (April 21, 1988)
  • K880894 — ALLERGIST SYRINGES (March 31, 1988)
  • K872875 — STRETCH GAUZE BANDAGES (September 4, 1987)
  • K872874 — MICROSCOPE COVER GLASSES (August 10, 1987)
  • K872797 — NON-SKID SHOE COVERS (August 4, 1987)
  • K871465 — THERMOMETER SHEATHS (May 11, 1987)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)

Other clearances for product code FXP

  • K971076 — PRIMED SHOE COVERS, PRIMED HEAD COVERS (January 13, 1998)
  • K971191 — FAR-EAST SHOE COVERS (July 10, 1997)
  • K970815 — CONVERTORS IMPERVIOUS SHOE COVERS (March 27, 1997)
  • K961342 — SHOE COVER, NON-STERILE (December 30, 1996)
  • K955835 — FLUID BARRIER BOOT KNEE & ANKLE-HIGH (November 19, 1996)
  • K952937 — NIOMED NON-SKID SHOE COVERS (October 23, 1995)
  • K952897 — NIOMED SHOE COVERS (October 23, 1995)
  • K943034 — OREX SHOE COVERS (January 2, 1995)
  • K932738 — KAPPLER PRO/VENT BOOT (March 29, 1994)
  • K925815 — REUSABLE LIQUIDPROOF BOOTIE (July 9, 1993)

FDA data resources