WHITE STAR

Alloy, Gold-based Noble Metal

JENERIC/PENTRON, INC.

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

Pre-market Notification Details

• Device ID: K945401
• 510k Number: K945401
• Device Name: WHITE STAR
• Classification: Alloy, Gold-based Noble Metal
• Applicant: JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724
• Contact: Linda D Rivard-leduc
• Correspondent: Linda D Rivard-leduc; JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724
• Product Code: EJT
• CFR Regulation Number: 872.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-03
• Decision Date: 1994-12-29