BITE BLOCK

Block, Bite

UNITED STATES ENDOSCOPY GROUP, INC.

The following data is part of a premarket notification filed by United States Endoscopy Group, Inc. with the FDA for Bite Block.

Pre-market Notification Details

• Device ID: K924304
• 510k Number: K924304
• Device Name: BITE BLOCK
• Classification: Block, Bite
• Applicant: UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094
• Contact: Lisa Scholz
• Correspondent: Lisa Scholz; UNITED STATES ENDOSCOPY GROUP, INC. 9905 HOBART RD. Waite Hill, OH 44094
• Product Code: JXL
• CFR Regulation Number: 882.5070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-08-26
• Decision Date: 1993-04-06