BAYSILEX

Material, Impression

CUTTER LABORATORIES, INC.

The following data is part of a premarket notification filed by Cutter Laboratories, Inc. with the FDA for Baysilex.

Pre-market Notification Details

• Device ID: K854106
• 510k Number: K854106
• Device Name: BAYSILEX
• Classification: Material, Impression
• Applicant: CUTTER LABORATORIES, INC. FOURTH AND PARKER STREETS BOX 1986 Berkeley, CA 94710
• Contact: Steven J Ojala
• Correspondent: Steven J Ojala; CUTTER LABORATORIES, INC. FOURTH AND PARKER STREETS BOX 1986 Berkeley, CA 94710
• Product Code: ELW
• CFR Regulation Number: 872.3660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1985-10-08
• Decision Date: 1986-03-17