510(k) Premarket Notification

• Device Classification Name: Device, Intravascular Catheter Securement
• 510(k) Number: K924180
• Device Name: I.V. PRO
• Applicant: I.V. - Pro Tek, Inc.; 2500 Bayport Blvd.; Seabrook, TX 77588
• Applicant Contact: WAYNE A SALLEE
• Correspondent: I.V. - Pro Tek, Inc.; 2500 Bayport Blvd.; Seabrook, TX 77588
• Correspondent Contact: WAYNE A SALLEE
• Regulation Number: 880.5210
• Classification Product Code: KMK
• Date Received: 08/19/1992
• Decision Date: 03/16/1993
• 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