MASKY

Resin, Denture, Relining, Repairing, Rebasing

PRESSING DI MONTICELLI RAG. STEFANO

The following data is part of a premarket notification filed by Pressing Di Monticelli Rag. Stefano with the FDA for Masky.

Pre-market Notification Details

• Device ID: K973542
• 510k Number: K973542
• Device Name: MASKY
• Classification: Resin, Denture, Relining, Repairing, Rebasing
• Applicant: PRESSING DI MONTICELLI RAG. STEFANO 4311 SW RESEARCH WAY Corvallis, OR 97333
• Contact: Thomas Maddux
• Correspondent: Thomas Maddux; PRESSING DI MONTICELLI RAG. STEFANO 4311 SW RESEARCH WAY Corvallis, OR 97333
• Product Code: EBI
• CFR Regulation Number: 872.3760 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-09-18
• Decision Date: 1998-02-10
• Summary: summary