MACOM

System, Image Processing, Radiological

A. STEIN - REGULATORY AFFAIRS CONSULTING

The following data is part of a premarket notification filed by A. Stein - Regulatory Affairs Consulting with the FDA for Macom.

Pre-market Notification Details

• Device ID: K973148
• 510k Number: K973148
• Device Name: MACOM
• Classification: System, Image Processing, Radiological
• Applicant: A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853
• Contact: Ahava Stein
• Correspondent: Ahava Stein; A. STEIN - REGULATORY AFFAIRS CONSULTING P.O.B. 454 Ginot Shomron, IL 44853
• Product Code: LLZ
• CFR Regulation Number: 892.2050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-08-22
• Decision Date: 1997-11-20