BITE BLOCK

Endoscopic Bite Block

ENDOSCOPIX

The following data is part of a premarket notification filed by Endoscopix with the FDA for Bite Block.

Pre-market Notification Details

• Device ID: K896691
• 510k Number: K896691
• Device Name: BITE BLOCK
• Classification: Endoscopic Bite Block
• Applicant: ENDOSCOPIX 18907 NORDHOFF 38B Northridge, CA 91324
• Contact: Michael Bradbury
• Correspondent: Michael Bradbury; ENDOSCOPIX 18907 NORDHOFF 38B Northridge, CA 91324
• Product Code: MNK
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-11-28
• Decision Date: 1990-02-12