Transcription of L</~g - Food and Drug Administration
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L</~g - Food and Drug Administration
L</~gJUN 1 8 2014510(k) SUMMARY OF SAFETY AND EFFECTIVENESS [21 CFIR (c)]Date Summary Was Prepared: June 13, 2014S ubmifter:Official Contact Person: Ronald J. Amen, Behalf of: Turkuaz SaglikHizmetleriMedikalTemizlikKimyasalU runleri Tic. Ltd. 67 Sok No: 3 EsenyurtISTANBUL TR-34513 Turkey90-212-4286848 Contacts: Nurhan IrmakDevice [ (a)(2)1 Trade or Proprietary name : KONIXG Sterile GelCommon or Usual name . Sterile Ultrasound GelClassification name : Transducer, Ultrasonic, Diagnostic(UCO) product Code: MUIR egulation Number: 21 CFR Class Class 11 Classification Panel RadiologyBy Prescription OnlyPredicate Device r80792(a)(3)1:KONIX Sterile Gel is substantially equivalent to:Sterile Aquasonic 100 Ultrasound Gel ( parker Laboratories)Description of the Device )(4)1:Konix Sterile Gel is an in vivo biocompatible sterile couplant intended foruse as a scanning gel in surgical procedures.]
Trade or Proprietary Name: KONIXG Sterile Gel ... FEATURES TURKUAZ PARKER LABS STERILE ... product radiation control provisions ...
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