PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2— 510(k) K122593
Substantially EquivalentOptim, LLC
FDA 510(k) clearance K122593 for PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2, Substantially Equivalent on 2012-09-13. Applicant: Optim, LLC.
Clearance details
- Applicant
- Optim, LLC
- Product code
- Code FEH
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Sturbridge, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.