Retraxil— 510(k) K243910

Substantially Equivalent

Kulzer, LLC

FDA 510(k) clearance K243910 for Retraxil, Substantially Equivalent on 2025-09-24. Applicant: Kulzer, LLC. Device class: Unclassified.

Clearance details

Applicant
Kulzer, LLC
Product code
Code MVL
Device class
Unclassified
Advisory panel
Unknown
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
South Bend, IN, US
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