510(k) K760517

CUP, DISPOSABLE MEDICINE by Landmark Plastics — Product Code KYX

K760517 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "CUP, DISPOSABLE MEDICINE". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Landmark Plastics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1976
Date Received
August 25, 1976
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