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Manufacturers
US
Optim, LLC
Medical Device Manufacturer
·
US , Sturbridge , MA
Optim, LLC - FDA 510(k) Cleared Devices
3 submissions
·
3 cleared
·
Since 2012
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Optim, LLC
Gastroenterology & Urology
✕
2
devices
1-2 of 2
Filters
Cleared
Apr 19, 2013
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
K130489
·
FEH
Gastroenterology & Urology
·
53d
Cleared
Sep 13, 2012
PRECISION ENDOSCOPIC INFRARED COAGULATOR
K122593
·
FEH
Gastroenterology & Urology
·
20d
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3
Gastroenterology & Urology
2
Ear, Nose, Throat
1