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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: KXA
Date Received: 01/29/1999
Decision Date: 02/01/2001
Decision: 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: KXA
Date Received: 01/29/1999
Decision Date: 02/01/2001
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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