SMART SET

Set, Administration, Intravascular

TOPSPINS, INC.

The following data is part of a premarket notification filed by Topspins, Inc. with the FDA for Smart Set.

Pre-market Notification Details

• Device ID: K972663
• 510k Number: K972663
• Device Name: SMART SET
• Classification: Set, Administration, Intravascular
• Applicant: TOPSPINS, INC. 1642 GLOUCESTER Plymouth, MI 48170
• Contact: Martin R Prince
• Correspondent: Martin R Prince; TOPSPINS, INC. 1642 GLOUCESTER Plymouth, MI 48170
• Product Code: FPA
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-08
• Decision Date: 1997-09-02