510(k) Premarket Notification

• Device Classification Name: Set, Administration, Intravascular
• 510(k) Number: K853287
• Device Name: HUBOUT
• Applicant: I M, Inc.; P.O. Box 658; Fairfield, NJ 07004
• Applicant Contact: AMIR PORAT
• Correspondent: I M, Inc.; P.O. Box 658; Fairfield, NJ 07004
• Correspondent Contact: AMIR PORAT
• Regulation Number: 880.5440
• Classification Product Code: FPA
• Date Received: 08/05/1985
• Decision Date: 10/17/1985
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No