SPACER

Device, Percutaneous, Biopsy

BIP USA, INC.

The following data is part of a premarket notification filed by Bip Usa, Inc. with the FDA for Spacer.

Pre-market Notification Details

• Device ID: K925870
• 510k Number: K925870
• Device Name: SPACER
• Classification: Device, Percutaneous, Biopsy
• Applicant: BIP USA, INC. 727 MAIN ST. Niagara Falls, NY 14301
• Contact: Gary Horner
• Correspondent: Gary Horner; BIP USA, INC. 727 MAIN ST. Niagara Falls, NY 14301
• Product Code: MJG
• CFR Regulation Number: 878.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1992-11-19
• Decision Date: 1993-05-19