GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER

Barrier, Animal Source, Intraoral

GEISTLICH PHARMA AG

The following data is part of a premarket notification filed by Geistlich Pharma Ag with the FDA for Geistlich Mucograft: 15 X 20 Mm, 20 X 30 Mm, 8 Mm Diameter.

Pre-market Notification Details

• Device ID: K140518
• 510k Number: K140518
• Device Name: GEISTLICH MUCOGRAFT: 15 X 20 MM, 20 X 30 MM, 8 MM DIAMETER
• Classification: Barrier, Animal Source, Intraoral
• Applicant: GEISTLICH PHARMA AG 555 Twelfth Street, NW Washington, DC 20004
• Contact: Daniel A Kracov
• Correspondent: Daniel A Kracov; GEISTLICH PHARMA AG 555 Twelfth Street, NW Washington, DC 20004
• Product Code: NPL
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-02-28
• Decision Date: 2014-07-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07610221011308	K140518	000