ENCORE

Colorimeter, Photometer, Spectrophotometer For Clinical Use

HERAEUS KULZER, INC.

The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Encore.

Pre-market Notification Details

• Device ID: K915113
• 510k Number: K915113
• Device Name: ENCORE
• Classification: Colorimeter, Photometer, Spectrophotometer For Clinical Use
• Applicant: HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004
• Contact: Rosanne M.sovol
• Correspondent: Rosanne M.sovol; HERAEUS KULZER, INC. 430 S. BEIGER ST. P.O. BOX 2004 Mishawaka, IN 46546 -2004
• Product Code: JJQ
• CFR Regulation Number: 862.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-11-13
• Decision Date: 1992-03-18