I.V. FILTER EXTENSION SET

Filter, Infusion Line

FILTERTEK, INC.

The following data is part of a premarket notification filed by Filtertek, Inc. with the FDA for I.v. Filter Extension Set.

Pre-market Notification Details

• Device ID: K912848
• 510k Number: K912848
• Device Name: I.V. FILTER EXTENSION SET
• Classification: Filter, Infusion Line
• Applicant: FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034
• Contact: Larry Larkin
• Correspondent: Larry Larkin; FILTERTEK, INC. P.O. BOX 310 PRICE RD. Hebron, IL 60034
• Product Code: FPB
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-06-28
• Decision Date: 1991-11-29