510(k) K935189
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