Regenomer® Syringe, Regenomer® Plug, Regenomer® Block

Bone Grafting Material, Animal Source

NIBEC CO, LTD

The following data is part of a premarket notification filed by Nibec Co, Ltd with the FDA for Regenomer® Syringe, Regenomer® Plug, Regenomer® Block.

Pre-market Notification Details

• Device ID: K150079
• 510k Number: K150079
• Device Name: Regenomer® Syringe, Regenomer® Plug, Regenomer® Block
• Classification: Bone Grafting Material, Animal Source
• Applicant: NIBEC CO, LTD IWOL ELECTRICITY-ELECTRONIC AGRO-INDUSTRIAL COMPLEX, 1127, SINWO-RI, IWOL-MYEON Jincheon-gun, KR 365-824
• Contact: Yoon-jeong Park
• Correspondent: Takashi Yamada; SMILE US 22395 S WESTERN AVENUE, SUITE 304 Torrance, CA 90501
• Product Code: NPM
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-01-15
• Decision Date: 2015-12-10
• Summary: summary