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FDA 510(k), K964661, HX-20/21-1 ENDOSCOPIC LIGATOR
FDA 510(k), K964661, HX-20/21-1 ENDOSCOPIC LIGATOR
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510(K) Number: K964661
Device Name: HX-20/21-1 ENDOSCOPIC LIGATOR
Manufacturer: SUBHASH PATEL
Device Classification Name: Ligator, Esophageal
Regulation Number: MND
Classification Product Code: KXA
Date Received: 11/20/1996
Decision Date: 10/30/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: HX-20/21-1 ENDOSCOPIC LIGATOR
Manufacturer: SUBHASH PATEL
Device Classification Name: Ligator, Esophageal
Regulation Number: MND
Classification Product Code: KXA
Date Received: 11/20/1996
Decision Date: 10/30/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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