SNORKEL

Device, Jaw Repositioning

FELLMAR COMPANY

The following data is part of a premarket notification filed by Fellmar Company with the FDA for Snorkel.

Pre-market Notification Details

• Device ID: K112766
• 510k Number: K112766
• Device Name: SNORKEL
• Classification: Device, Jaw Repositioning
• Applicant: FELLMAR COMPANY 2670 S MYRTLE AVE. #106 Monrovia, CA 91016
• Contact: Wayne Marshall
• Correspondent: Wayne Marshall; FELLMAR COMPANY 2670 S MYRTLE AVE. #106 Monrovia, CA 91016
• Product Code: LQZ
• CFR Regulation Number: 872.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-09-22
• Decision Date: 2012-06-04
• Summary: summary