UNINHIBITED

Coating, Filling Material, Resin

BISCO, INC.

The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Uninhibited.

Pre-market Notification Details

• Device ID: K021503
• 510k Number: K021503
• Device Name: UNINHIBITED
• Classification: Coating, Filling Material, Resin
• Applicant: BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Contact: Stephen (steve) Smith
• Correspondent: Stephen (steve) Smith; BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193
• Product Code: EBD
• CFR Regulation Number: 872.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-05-09
• Decision Date: 2002-08-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D798PRO0	K021503	000