ProSeal™ Closed System Drug Transfer Device (CSTD)

Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System

Epic Medical Pte. Ltd.

The following data is part of a premarket notification filed by Epic Medical Pte. Ltd. with the FDA for Proseal™ Closed System Drug Transfer Device (cstd).

Pre-market Notification Details

• Device ID: K192075
• 510k Number: K192075
• Device Name: ProSeal™ Closed System Drug Transfer Device (CSTD)
• Classification: Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
• Applicant: Epic Medical Pte. Ltd. 10 Jalan Besar, #06-04, Sim Lim Tower Singapore, SG 208787
• Contact: Freddie Lee
• Correspondent: Roshana Ahmed; G&L Scientific, Inc. 25 Independence Blvd. Warren, NJ 07059
• Product Code: ONB
• CFR Regulation Number: 880.5440 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-08-02
• Decision Date: 2020-08-07