HANDI-FOAM

Accelerator, Linear, Medical

MEDTEC, INC.

The following data is part of a premarket notification filed by Medtec, Inc. with the FDA for Handi-foam.

Pre-market Notification Details

• Device ID: K935021
• 510k Number: K935021
• Device Name: HANDI-FOAM
• Classification: Accelerator, Linear, Medical
• Applicant: MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041
• Contact: Donald Riibe
• Correspondent: Donald Riibe; MEDTEC, INC. 1401 8TH ST. S.E. P.O. BOX 602 Orange City, IA 51041
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-10-20
• Decision Date: 1994-04-07