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 IDK192075
510k NumberK192075
Device Name:ProSeal™ Closed System Drug Transfer Device (CSTD)
ClassificationClosed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Applicant Epic Medical Pte. Ltd. 10 Jalan Besar, #06-04, Sim Lim Tower Singapore,  SG 208787
ContactFreddie Lee
CorrespondentRoshana Ahmed
G&L Scientific, Inc. 25 Independence Blvd. Warren,  NJ  07059
Product CodeONB  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-02
Decision Date2020-08-07

Trademark Results [ProSeal]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROSEAL
PROSEAL
98574834 not registered Live/Pending
Thermofluid Technologies, Inc.
2024-05-29
PROSEAL
PROSEAL
86689537 5115384 Live/Registered
TELEFLEX LIFE SCIENCES UNLIMITED COMPANY
2015-07-10
PROSEAL
PROSEAL
85123375 not registered Dead/Abandoned
Auto Care Products, Inc.
2010-09-04
PROSEAL
PROSEAL
79191154 5308741 Live/Registered
Proseal UK Ltd
2016-07-05
PROSEAL
PROSEAL
79090895 4008236 Live/Registered
Otto Bock HealthCare GmbH
2010-10-22
PROSEAL
PROSEAL
78850068 not registered Dead/Abandoned
Verimark (Pty) Limited
2006-03-30
PROSEAL
PROSEAL
78391278 not registered Dead/Abandoned
Provencher Plumbing and Heating
2004-03-26
PROSEAL
PROSEAL
78300757 not registered Dead/Abandoned
ProSeal Chicago, Inc.
2003-09-16
PROSEAL
PROSEAL
78165113 2953070 Live/Registered
DELAWARE CAPITAL FORMATION, INC.
2002-09-17
PROSEAL
PROSEAL
76542026 not registered Dead/Abandoned
BRIDGESTONE CORPORATION
2003-09-02
PROSEAL
PROSEAL
76428088 not registered Dead/Abandoned
TRIM-GARD COMPANY LIMITED
2002-07-08
PROSEAL
PROSEAL
76337950 not registered Dead/Abandoned
BRIDGESTONE CORPORATION
2001-11-15

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