Home / 510(k) Clearances / K780608

510(k) K780608

ICE BAG, VINYL by Abco Dealers, Inc. — Product Code KYR

K780608 is an FDA 510(k) premarket notification submitted by Abco Dealers, Inc. for the device "ICE BAG, VINYL". The FDA issued a decision of Substantially Equivalent on June 6, 1978. The device falls under product code KYR (Bag, Ice), a Class I device regulated under 21 CFR 880.6050. Abco Dealers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1978
Date Received
April 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Ice
Device Class
Class I
Regulation Number
880.6050
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)
  • K862726 — DISPOSABLE SHOE COVERS AND NURSES CAPS (August 1, 1986)
  • K862111 — ARMBOARDS, REUSABLE AND DISPOSABLE (July 8, 1986)

Other clearances for product code KYR

  • K833872 — SAV-A-LIMB (February 4, 1984)
  • K810653 — VINYL ICE BAG (March 27, 1981)
  • K760951 — DEVON COOL FACE (December 30, 1976)

FDA data resources