EPIGUARD

Block, Bite

EPISAFE MEDICAL DEVICES, LTD.

The following data is part of a premarket notification filed by Episafe Medical Devices, Ltd. with the FDA for Epiguard.

Pre-market Notification Details

• Device ID: K050188
• 510k Number: K050188
• Device Name: EPIGUARD
• Classification: Block, Bite
• Applicant: EPISAFE MEDICAL DEVICES, LTD. 291 Hillside Avenue Somerset, MA 02726
• Contact: George J Hattub
• Correspondent: George J Hattub; EPISAFE MEDICAL DEVICES, LTD. 291 Hillside Avenue Somerset, MA 02726
• Product Code: JXL
• CFR Regulation Number: 882.5070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-01-27
• Decision Date: 2005-04-27
• Summary: summary