MUCOHARD

Resin, Denture, Relining, Repairing, Rebasing

PARKELL, INC.

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

Pre-market Notification Details

• Device ID: K053516
• 510k Number: K053516
• Device Name: MUCOHARD
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Contact: Nelson J Gendusa
• Correspondent: Nelson J Gendusa; PARKELL, INC. 155 SCHMITT BLVD. P.O. BOX 376 Farmingdale, NY 11735
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-16
• Decision Date: 2006-01-26
• Summary: summary