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FDA 510(k), K043115, LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
FDA 510(k), K043115, LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
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510(K) Number: K043115
Device Name: LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
Manufacturer: ORLY MAOR
Device Classification Name: Clip, Implantable
Regulation Number: FZP
Classification Product Code: KXA
Date Received: 11/10/2004
Decision Date: 12/01/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC)
Manufacturer: ORLY MAOR
Device Classification Name: Clip, Implantable
Regulation Number: FZP
Classification Product Code: KXA
Date Received: 11/10/2004
Decision Date: 12/01/2004
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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