510(k) K864188

E-Z HOLD WITH ADHESIVE BASE.-#4065 by John F. Greer Co., Inc. — Product Code KNX

K864188 is an FDA 510(k) premarket notification submitted by John F. Greer Co., Inc. for the device "E-Z HOLD WITH ADHESIVE BASE.-#4065". The FDA issued a decision of Substantially Equivalent on December 4, 1986. The device falls under product code KNX (Collector, Urine, (And Accessories) For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. John F. Greer Co., Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1986
Date Received
October 27, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Collector, Urine, (And Accessories) For Indwelling Catheter
Device Class
Class II
Regulation Number
876.5250
Review Panel
GU
Submission Type