FDA 510(k), K013904, BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230

FDA 510(k), K013904, BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230

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510(K) Number: K013904
Device Name: BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230
Manufacturer: KRIS SHAH
Device Classification Name: Electrosurgical, Cutting & Coagulation & Accessories
Regulation Number: GEI
Classification Product Code: KXA
Date Received: 11/26/2001
Decision Date: 02/12/2002
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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