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510(k) clearance

ColActive Plus

FDA 510(k) source

510(k) number
K260652
Applicant
Covalon Technologies, Ltd.
Decision date
Sep 9, 2026
Date received
Feb 27, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
KGN
Device type
Wound Dressing With Animal-Derived Material(S)
Device class
Unclassified
Advisory committee
Unknown
Statement or summary
Summary
Third party
N
Location
Mississauga, CA