K122593

Substantially Equivalent

PRECISION ENDOSCOPIC INFRARED COAGULATOR; MODEL 5100 SINGLE-USE DISPOSABLE MAXI-GUIDE FLEXIBLE LIGHTGUIDE; MODEL 5100-2

Applicant: Optim, LLC
Product code: FEH
Advisory panel: Gastroenterology, Urology
Date received: 2012-08-24
Decision date: 2012-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Sturbridge, MA, US

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