510(k) Premarket Notification

• Device Classification Name: i.v. start kit
• 510(k) Number: K863712
• Device Name: I.V. START KIT, STERILE, DISPOSABLES
• Applicant: BUSSE HOSPITAL DISPOSABLES, INC.; P.O. BOX 11067; HAUPPAUGE, NY 11788
• Applicant Contact: PARTHA BASUMALLIK
• Correspondent: BUSSE HOSPITAL DISPOSABLES, INC.; P.O. BOX 11067; HAUPPAUGE, NY 11788
• Correspondent Contact: PARTHA BASUMALLIK
• Regulation Number: 880.5200
• Classification Product Code: LRS
• Date Received: 09/23/1986
• Decision Date: 10/22/1986
• 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