UNIVERSAL IRRIGATION SOLUTION HYBRID

Endoscopic Irrigation/suction System

BYRNE MEDICAL, INC.

The following data is part of a premarket notification filed by Byrne Medical, Inc. with the FDA for Universal Irrigation Solution Hybrid.

Pre-market Notification Details

• Device ID: K102855
• 510k Number: K102855
• Device Name: UNIVERSAL IRRIGATION SOLUTION HYBRID
• Classification: Endoscopic Irrigation/suction System
• Applicant: BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe, TX 77303
• Contact: John Willis
• Correspondent: John Willis; BYRNE MEDICAL, INC. 3150 POLLOCK DR. Conroe, TX 77303
• Product Code: OCX
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-09-29
• Decision Date: 2010-11-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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