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FDA 510(k), K131234, LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
FDA 510(k), K131234, LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
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$49.00 USD
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$49.00 USD
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510(K) Number: K131234
Device Name: LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
Manufacturer: MAHTAB FATEMI
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 05/01/2013
Decision Date: 10/15/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
Device Name: LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)
Manufacturer: MAHTAB FATEMI
Device Classification Name: Bronchoscope (Flexible Or Rigid)
Regulation Number: EOQ
Classification Product Code: KXA
Date Received: 05/01/2013
Decision Date: 10/15/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ear Nose & Throat
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