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510(k) K780599

SYRINGE, EAR & ULCER by Abco Dealers, Inc. — Product Code KCP

K780599 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "SYRINGE, EAR & ULCER". The FDA issued a decision of Substantially Equivalent on April 19, 1978. The device falls under product code KCP (Syringe, Ent), a Class I device regulated under 21 CFR 874.5220. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1978
Date Received
April 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Ent
Device Class
Class I
Regulation Number
874.5220
Review Panel
EN
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 KCP

  • K840311 — CAT. 7-EAR, NOSE & THROAT DEVICES (May 9, 1984)
  • K822754 — EAR/ULCER SYRINGE (October 4, 1982)
  • K810284 — AUTOMATIC TEFLON INJECTION SYRINGE (March 11, 1981)

FDA data resources