MYSHELL

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

SEDAT S.A.

The following data is part of a premarket notification filed by Sedat S.a. with the FDA for Myshell.

Pre-market Notification Details

• Device ID: K040498
• 510k Number: K040498
• Device Name: MYSHELL
• Classification: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
• Applicant: SEDAT S.A. 4 HARVARD PLACE, # 1 Charlestown, MA 02129
• Contact: Peter C Wood
• Correspondent: Peter C Wood; SEDAT S.A. 4 HARVARD PLACE, # 1 Charlestown, MA 02129
• Product Code: DTL
• CFR Regulation Number: 870.4290 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-02-26
• Decision Date: 2004-07-02
• Summary: summary