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510(k) K771539

STEPPER by Tridak — Product Code KYX

K771539 is an FDA 510(k) premarket notification submitted by Tridak for the device "STEPPER". The FDA issued a decision of Substantially Equivalent on October 7, 1977. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 1977
Date Received
August 11, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dispenser, Liquid Medication
Device Class
Class I
Regulation Number
880.6430
Review Panel
HO
Submission Type

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  • K954181 — CANYONS BI-DIRECTIONAL CHECK VALVE (November 29, 1995)
  • K830571 — BOTTLE ADAPTER (March 24, 1983)
  • K801008 — MULTI-AD FLUID DISPENSING PUMP MP-3000 (June 2, 1980)
  • K800437 — SYRINGE TIP CONNECTOR (March 12, 1980)
  • K800362 — FLUID DISPENSING SYSTEM (March 12, 1980)
  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)
  • K781364 — PINT BOTTLE WELL (October 17, 1978)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)

FDA data resources