1ST IMPRESSION

Material, Impression

DEN-MAT CORP.

The following data is part of a premarket notification filed by Den-mat Corp. with the FDA for 1st Impression.

Pre-market Notification Details

• Device ID: K983106
• 510k Number: K983106
• Device Name: 1ST IMPRESSION
• Classification: Material, Impression
• Applicant: DEN-MAT CORP. 2727 SKYWAY DR. Santa Maria, CA 93455
• Contact: W R Glace
• Correspondent: W R Glace; DEN-MAT CORP. 2727 SKYWAY DR. Santa Maria, CA 93455
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-09-04
• Decision Date: 1999-02-09