RALCO

Collimator, Manual, Radiographic

RALCO S.R.L.

The following data is part of a premarket notification filed by Ralco S.r.l. with the FDA for Ralco.

Pre-market Notification Details

• Device ID: K110856
• 510k Number: K110856
• Device Name: RALCO
• Classification: Collimator, Manual, Radiographic
• Applicant: RALCO S.R.L. 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; RALCO S.R.L. 8870 RAVELLO CT Naples, FL 34114
• Product Code: IZX
• CFR Regulation Number: 892.1610 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-03-28
• Decision Date: 2011-08-10
• Summary: summary