REVERSO

Accessories, Blood Circuit, Hemodialysis

MEDISYSTEMS CORP.

The following data is part of a premarket notification filed by Medisystems Corp. with the FDA for Reverso.

Pre-market Notification Details

• Device ID: K994306
• 510k Number: K994306
• Device Name: REVERSO
• Classification: Accessories, Blood Circuit, Hemodialysis
• Applicant: MEDISYSTEMS CORP. 1201 3RD AVE. SUITE 3900 Seattle, WA 98101 -3016
• Contact: Fredric G Swindler
• Correspondent: Fredric G Swindler; MEDISYSTEMS CORP. 1201 3RD AVE. SUITE 3900 Seattle, WA 98101 -3016
• Product Code: KOC
• CFR Regulation Number: 876.5820 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-12-21
• Decision Date: 2000-03-20
• Summary: summary