510(k) K935060

BRENNEN MEDICAL STERILE SALINE SOLUTION by Brennen Medical, Inc. — Product Code KMF

K935060 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "BRENNEN MEDICAL STERILE SALINE SOLUTION". The FDA issued a decision of Substantially Equivalent on January 10, 1994. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Brennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1994
Date Received
October 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bandage, Liquid
Device Class
Class I
Regulation Number
880.5090
Review Panel
SU
Submission Type