510(k) K243071

Bovine Dermis Collagen Dermal Matrix by Collagen Matrix, Inc. — Product Code KGN

K243071 is an FDA 510(k) premarket notification submitted by Collagen Matrix, Inc. for the device "Bovine Dermis Collagen Dermal Matrix". The FDA issued a decision of Substantially Equivalent on December 19, 2024. The device falls under product code KGN (Wound Dressing With Animal-Derived Material(S)), a Class U device. Collagen Matrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2024
Date Received
September 27, 2024
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