REPLICA

Material, Impression

MATECH, INC.

The following data is part of a premarket notification filed by Matech, Inc. with the FDA for Replica.

Pre-market Notification Details

• Device ID: K925746
• 510k Number: K925746
• Device Name: REPLICA
• Classification: Material, Impression
• Applicant: MATECH, INC. 13038 SAN FERNANDO RD. Sylmar, CA 91342
• Contact: Paul L Saxton
• Correspondent: Paul L Saxton; MATECH, INC. 13038 SAN FERNANDO RD. Sylmar, CA 91342
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-13
• Decision Date: 1994-01-21

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00843471100127	K925746	000
00843471100103	K925746	000