Medley

Lubricant, Personal

Good Clean Love, Inc.

The following data is part of a premarket notification filed by Good Clean Love, Inc. with the FDA for Medley.

Pre-market Notification Details

• Device ID: K212000
• 510k Number: K212000
• Device Name: Medley
• Classification: Lubricant, Personal
• Applicant: Good Clean Love, Inc. 207 W 5th Avenue Eugene, OR 97401
• Contact: Wendy Strgar
• Correspondent: Abhishek Gurnani; Amin Talati Wasserman LLP 100 S Wacker Drive Suite 2000 Chicago, IL 60606
• Product Code: NUC
• CFR Regulation Number: 884.5300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-06-28
• Decision Date: 2021-11-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850014621575	K212000	000
30850014621781	K212000	000