SUPER TISSUE

Accelerator, Linear, Medical

I.Z.I. CORP.

The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for Super Tissue.

Pre-market Notification Details

• Device ID: K993742
• 510k Number: K993742
• Device Name: SUPER TISSUE
• Classification: Accelerator, Linear, Medical
• Applicant: I.Z.I. CORP. P.O. BOX 4321 Crofton, MD 21114
• Contact: E.j. Smith
• Correspondent: E.j. Smith; I.Z.I. CORP. P.O. BOX 4321 Crofton, MD 21114
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-11-04
• Decision Date: 2000-02-02