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510(k) K143177

KleenGel Dispenser by Kleengel, LLC — Product Code KYX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2015
Date Received
November 4, 2014
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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  • K792227 — MULTI-AD FLUID DISPENSING SYSTEM (December 20, 1979)
  • K781364 — PINT BOTTLE WELL (October 17, 1978)
  • K771539 — STEPPER (October 7, 1977)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)