MANIFOLD

Apparatus, Suction, Operating-room, Wall Vacuum Powered

WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS)

The following data is part of a premarket notification filed by Westmark, Sterile Packing Systems, Inc. (sps) with the FDA for Manifold.

Pre-market Notification Details

• Device ID: K896804
• 510k Number: K896804
• Device Name: MANIFOLD
• Classification: Apparatus, Suction, Operating-room, Wall Vacuum Powered
• Applicant: WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507
• Contact: Sury Shoney
• Correspondent: Sury Shoney; WESTMARK, STERILE PACKING SYSTEMS, INC. (SPS) 1253 RAMONA ST. S.E. Grand Rapids, MI 49507
• Product Code: GCX
• CFR Regulation Number: 880.6740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1989-12-01
• Decision Date: 1990-02-08