510(k) Premarket Notification

• Device Classification Name: catheter, intravascular, therapeutic, short-term less than 30 days
• 510(k) Number: K952058
• Device Name: STERILE V.A.D. (VASCULAR ACCESS DEVICES) ACCESS KIT, DISPOSABLE
• Applicant: TRINITY LABORATORIES, INC.; 201 KILEY DR.; P.O. BOX 1818; SALISBURY, MD 21802
• Applicant Contact: PARTHA BASUMALLIK
• Correspondent: TRINITY LABORATORIES, INC.; 201 KILEY DR.; P.O. BOX 1818; SALISBURY, MD 21802
• Correspondent Contact: PARTHA BASUMALLIK
• Regulation Number: 880.5200
• Classification Product Code: FOZ
• Date Received: 05/02/1995
• Decision Date: 09/21/1995
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General Hospital
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No