GENTLE FEEL

Shield, Nipple

MALI, INC.

The following data is part of a premarket notification filed by Mali, Inc. with the FDA for Gentle Feel.

Pre-market Notification Details

• Device ID: K864176
• 510k Number: K864176
• Device Name: GENTLE FEEL
• Classification: Shield, Nipple
• Applicant: MALI, INC. 18455 BURBACK BLVD, STE 411 TARZANA, CA 91356
• Contact: CAROLE HIRSCH
• Correspondent: CAROLE HIRSCH; MALI, INC. 18455 BURBACK BLVD, STE 411 TARZANA, CA 91356
• Product Code: HFS
• CFR Regulation Number: 880.5630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-10-24
• Decision Date: 1986-11-04