510(k) K781364

PINT BOTTLE WELL by Baxa Corp., Sub. of Cook Group, Inc. — Product Code KYX

K781364 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "PINT BOTTLE WELL". The FDA issued a decision of Substantially Equivalent on October 17, 1978. The device falls under product code KYX (Dispenser, Liquid Medication), a Class I device regulated under 21 CFR 880.6430. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
August 7, 1978
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