PARAGON

Alloy, Other Noble Metal

JENERIC/PENTRON, INC.

The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Paragon.

Pre-market Notification Details

• Device ID: K922957
• 510k Number: K922957
• Device Name: PARAGON
• Classification: Alloy, Other Noble Metal
• Applicant: JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492
• Contact: Arun Prasad
• Correspondent: Arun Prasad; JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492
• Product Code: EJS
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-06-18
• Decision Date: 1992-09-14