510(k) Premarket Notification

• Device Classification Name: I.V. Start Kit
• 510(k) Number: K922533
• Device Name: IV START KIT CUSTOM SMP # A-Z
• Applicant: SPECIALTY MEDICAL PRODUCTS CO.; 1604 MERRILL DR.; SUITE D; LITTLE ROCK, AK 72212
• Applicant Contact: JOHN LAMB
• Correspondent: SPECIALTY MEDICAL PRODUCTS CO.; 1604 MERRILL DR.; SUITE D; LITTLE ROCK, AK 72212
• Correspondent Contact: JOHN LAMB
• Regulation Number: 880.5200
• Classification Product Code: LRS
• Date Received: 05/28/1992
• Decision Date: 03/23/1993
• Decision: Substantially Equivalent - Kit With Drugs (SEKD)
• Regulation Medical Specialty: General Hospital
• 510k Review Panel: General & Plastic Surgery
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No