WIRE

Applier, Cerclage

PLASTAFIL, INC.

The following data is part of a premarket notification filed by Plastafil, Inc. with the FDA for Wire.

Pre-market Notification Details

• Device ID: K841628
• 510k Number: K841628
• Device Name: WIRE
• Classification: Applier, Cerclage
• Applicant: PLASTAFIL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: HXN
• CFR Regulation Number: 888.4540 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1984-04-19
• Decision Date: 1984-07-23