510(k) K935189

E-Z DERM BIOSYNTHETIC WOUND DRESSING by Brennen Medical, Inc. — Product Code KGN

K935189 is an FDA 510(k) premarket notification submitted by Brennen Medical, Inc. for the device "E-Z DERM BIOSYNTHETIC WOUND DRESSING". The FDA issued a decision of SN on July 11, 1994. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Brennen Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 11, 1994
Date Received
October 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wound Dressing With Animal-Derived Material(S)
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type