510(k) Premarket Notification

• Device Classification Name: Anesthesia Conduction Kit
• 510(k) Number: K884552
• Device Name: CONTINUOUS EPIDURAL ANESTHESIA KIT W/POLY CATHETER
• Applicant: ARROW INTL., INC.; P.O. BOX 6306; HILL AND GEORGE AVENUES; READING, PA 19610
• Applicant Contact: THOMAS D NICKEL
• Correspondent: ARROW INTL., INC.; P.O. BOX 6306; HILL AND GEORGE AVENUES; READING, PA 19610
• Correspondent Contact: THOMAS D NICKEL
• Regulation Number: 868.5140
• Classification Product Code: CAZ
• Date Received: 10/31/1988
• Decision Date: 03/14/1989
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Anesthesiology
• 510k Review Panel: Anesthesiology
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls