COSMOS

Tube Mount, X-ray, Diagnostic

PAUSCH CORP.

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

Pre-market Notification Details

• Device ID: K870856
• 510k Number: K870856
• Device Name: COSMOS
• Classification: Tube Mount, X-ray, Diagnostic
• Applicant: PAUSCH CORP. 96 BIRCH AVE. Little Silver, NJ 07739
• Contact: J. H Tice
• Correspondent: J. H Tice; PAUSCH CORP. 96 BIRCH AVE. Little Silver, NJ 07739
• Product Code: IYB
• CFR Regulation Number: 892.1770 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1987-03-03
• Decision Date: 1987-03-30