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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device magnetic surgical system
Regulation Description Magnetic surgical instrument system.
Definition System designed to grasp and retract the body and the fundus of the gallbladder in laparoscopic cholecystectomy procedures to facilitate access and visualization of the surgical site. The device is indicated for use in patients within a BMI range of 20 to 34 kg/m2. The device is intended for prescription use only.
Product CodePNL
Regulation Number 878.4815
Device Class 2


Premarket Reviews
ManufacturerDecision
LEVITA MAGNETICS INTERNATIONAL CORP.
  SUBSTANTIALLY EQUIVALENT 2

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