FLOW EASE(PLASTIC VENTED NEEDLE)

Set, I.v. Fluid Transfer

ACACIA, INC.

The following data is part of a premarket notification filed by Acacia, Inc. with the FDA for Flow Ease(plastic Vented Needle).

Pre-market Notification Details

• Device ID: K853212
• 510k Number: K853212
• Device Name: FLOW EASE(PLASTIC VENTED NEEDLE)
• Classification: Set, I.v. Fluid Transfer
• Applicant: ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354
• Contact: James Sullivan
• Correspondent: James Sullivan; ACACIA, INC. P.O. BOX 1240 Loma Linda, CA 92354
• Product Code: LHI
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-07-31
• Decision Date: 1985-09-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10810080610030	K853212	000
10810080610047	K853212	000