TUTOPATCH

Mesh, Surgical

TUTOGEN MEDICAL U.S., INC.

The following data is part of a premarket notification filed by Tutogen Medical U.s., Inc. with the FDA for Tutopatch.

Pre-market Notification Details

• Device ID: K991296
• 510k Number: K991296
• Device Name: TUTOPATCH
• Classification: Mesh, Surgical
• Applicant: TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING Alachua, FL 32615
• Contact: Pj Pardo
• Correspondent: Pj Pardo; TUTOGEN MEDICAL U.S., INC. 13709 PROGRESS BLVD. BOX 19 SOUTH WING Alachua, FL 32615
• Product Code: FTM
• Subsequent Product Code: DXZ
• Subsequent Product Code: OXH
• Subsequent Product Code: PAJ
• CFR Regulation Number: 878.3300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-04-15
• Decision Date: 2000-10-06
• Summary: summary