510(k) K851539

CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO by Chesebrough-Pond'S U.S.A. Co. — Product Code KNT

K851539 is an FDA 510(k) premarket notification submitted by Chesebrough-Pond'S U.S.A. Co. for the device "CHESEBROUGH-PONDS KANGAROO PUMP SET W/EASY-CAP CLO". The FDA issued a decision of Substantially Equivalent on June 12, 1985. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Chesebrough-Pond'S U.S.A. Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 1985
Date Received
April 16, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type