I.V. START KIT

Set, Administration, Intravascular

MARWOOD MEDICAL, INC.

The following data is part of a premarket notification filed by Marwood Medical, Inc. with the FDA for I.v. Start Kit.

Pre-market Notification Details

• Device ID: K840619
• 510k Number: K840619
• Device Name: I.V. START KIT
• Classification: Set, Administration, Intravascular
• Applicant: MARWOOD MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-02-14
• Decision Date: 1984-03-27