510(k) Premarket Notification

• Device Classification Name: I.V. Start Kit
• 510(k) Number: K863796
• Device Name: CREATIVE CARE SYSTEMS' IV START KIT
• Applicant: AMERICAN BIOMATERIALS CORP.; P.O. BOX 3543; PRINCETON, NJ 08543
• Applicant Contact: JUDITH E O'GRADY,RN
• Correspondent: AMERICAN BIOMATERIALS CORP.; P.O. BOX 3543; PRINCETON, NJ 08543
• Correspondent Contact: JUDITH E O'GRADY,RN
• Regulation Number: 880.5200
• Classification Product Code: LRS
• Date Received: 09/29/1986
• Decision Date: 11/28/1986
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General & Plastic Surgery
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No