FDA 510(k), K020936, 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
FDA 510(k), K020936, 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
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510(K) Number: K020936
Device Name: 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
Manufacturer: MEDCOMP
Device Classification Name: catheter, hemodialysis, implanted
Regulation Number: 876.5540
Classification Product Code: MSD
Date Received: 03/22/2002
Decision Date: 10/11/2002
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: 10F X 18CM PEDIATRIC ASH SPLIT CATH XL, MODEL ASPC18P-XL; 10F X 24CM PEDIATRIC ASH SPLIT-CATH XL, MODEL ASPC24P-XL
Manufacturer: MEDCOMP
Device Classification Name: catheter, hemodialysis, implanted
Regulation Number: 876.5540
Classification Product Code: MSD
Date Received: 03/22/2002
Decision Date: 10/11/2002
Regulation Medical Specialty: Gastroenterology/Urology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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