INTREX

Unit, X-ray, Intraoral

PENNWALT CORP.

The following data is part of a premarket notification filed by Pennwalt Corp. with the FDA for Intrex.

Pre-market Notification Details

• Device ID: K833241
• 510k Number: K833241
• Device Name: INTREX
• Classification: Unit, X-ray, Intraoral
• Applicant: PENNWALT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: EAP
• CFR Regulation Number: 872.1810 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-08-22
• Decision Date: 1983-10-28