I.V. ADMINISTRATION SET

Set, Administration, Intravascular

QUEST MEDICAL, INC.

The following data is part of a premarket notification filed by Quest Medical, Inc. with the FDA for I.v. Administration Set.

Pre-market Notification Details

• Device ID: K811685
• 510k Number: K811685
• Device Name: I.V. ADMINISTRATION SET
• Classification: Set, Administration, Intravascular
• Applicant: QUEST MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1981-06-15
• Decision Date: 1981-06-30