Home / 510(k) Clearances / K851309

510(k) K851309

ABCO PLASTIC UTENSILS by Abco Dealers, Inc. — Product Code KTC

K851309 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "ABCO PLASTIC UTENSILS". The FDA issued a decision of Substantially Equivalent on July 1, 1985. The device falls under product code KTC (Bath, Sitz, Nonpowered), a Class I device regulated under 21 CFR 890.5125. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 1985
Date Received
April 2, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Sitz, Nonpowered
Device Class
Class I
Regulation Number
890.5125
Review Panel
PM
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)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code KTC

  • K912179 — THE SPRITZ BATH (August 28, 1991)
  • K890085 — SIT-N-BATHE SITZ BATH (February 13, 1989)
  • K862600 — SITZ BATH (July 18, 1986)
  • K841711 — MAC LEE SITZ BATH (May 7, 1984)
  • K831762 — SITZ BATH, SINGLE PATIENT USE #8100 (June 24, 1983)
  • K800958 — PERSONAL SITZ BATH KIT (May 2, 1980)

FDA data resources