NEUTRALIZER

Stimulator, Nerve, Transcutaneous, For Pain Relief

SMITH AND NEPHEW DONJOY, INC.

The following data is part of a premarket notification filed by Smith And Nephew Donjoy, Inc. with the FDA for Neutralizer.

Pre-market Notification Details

• Device ID: K932320
• 510k Number: K932320
• Device Name: NEUTRALIZER
• Classification: Stimulator, Nerve, Transcutaneous, For Pain Relief
• Applicant: SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601
• Contact: Dan W Miller
• Correspondent: Dan W Miller; SMITH AND NEPHEW DONJOY, INC. 2777 LOKER AVENUE WEST Carsbad, CA 92008 -6601
• Product Code: GZJ
• CFR Regulation Number: 882.5890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-05-11
• Decision Date: 1993-10-06