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FDA 510(k), K990284, BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
FDA 510(k), K990284, BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
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510(K) Number: K990284
Device Name: BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
Manufacturer: KRIS SHAH
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 01/29/1999
Date Received: 02/01/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
Manufacturer: KRIS SHAH
Device Classification Name: Catheter, Septostomy
Regulation Number: DXF
Classification Product Code: 01/29/1999
Date Received: 02/01/2001
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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