MALLET

Impactor

PLASTAFIL, INC.

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

Pre-market Notification Details

• Device ID: K841627
• 510k Number: K841627
• Device Name: MALLET
• Classification: Impactor
• Applicant: PLASTAFIL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: HWA
• 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: 1984-08-27