Retraxil— 510(k) K243910

Substantially Equivalent

Kulzer, LLC

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

Clearance details

Applicant: Kulzer, LLC
Product code: Code MVL
Advisory panel: Unknown
Date received: 2024-12-19
Decision date: 2025-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

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