INQU

Filler, Bone Void, Calcium Compound

ISTO TECHNOLOGIES, INC.

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

Pre-market Notification Details

• Device ID: K063359
• 510k Number: K063359
• Device Name: INQU
• Classification: Filler, Bone Void, Calcium Compound
• Applicant: ISTO TECHNOLOGIES, INC. 1155 OLIVETTE EXEC. PKWY. SUITE 200 St. Louis, MO 63132
• Contact: Gary Gage
• Correspondent: Gary Gage; ISTO TECHNOLOGIES, INC. 1155 OLIVETTE EXEC. PKWY. SUITE 200 St. Louis, MO 63132
• Product Code: MQV
• CFR Regulation Number: 888.3045 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-07
• Decision Date: 2007-04-16
• Summary: summary