ENHANCE

Bone Grafting Material, Synthetic

PACKAGING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Enhance.

Pre-market Notification Details

• Device ID: K861041
• 510k Number: K861041
• Device Name: ENHANCE
• Classification: Bone Grafting Material, Synthetic
• Applicant: PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621
• Contact: Robert Fair
• Correspondent: Robert Fair; PACKAGING TECHNOLOGIES, INC. 262 GEMINI AVE. Brea, CA 92621
• Product Code: LYC
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1986-03-18
• Decision Date: 1986-05-30