510(k) K892442

KENDALL CURITY URETHRAL CATHETERS by The Kendal Co. — Product Code GBM

K892442 is an FDA 510(k) premarket notification submitted by The Kendal Co. for the device "KENDALL CURITY URETHRAL CATHETERS". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code GBM (Catheter, Urethral), a Class II device regulated under 21 CFR 876.5130. The Kendal Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
April 10, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type