The following data is part of a premarket notification filed by J & J Solutions, Inc. D/b/a/corvida Medical with the FDA for Halo.
Device ID | K150486 |
510k Number | K150486 |
Device Name: | Halo |
Classification | Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
Applicant | J & J Solutions, Inc. D/b/a/Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, IA 52241 |
Contact | Dana Schramm |
Correspondent | Dana Schramm J & J Solutions, Inc. D/b/a/Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, IA 52241 |
Product Code | ONB |
CFR Regulation Number | 880.5440 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-02-24 |
Decision Date | 2015-07-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20858743005066 | K150486 | 000 |
20858743005059 | K150486 | 000 |
20858743005042 | K150486 | 000 |
20858743005035 | K150486 | 000 |
20858743005028 | K150486 | 000 |
20858743005011 | K150486 | 000 |
20858743005004 | K150486 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HALO 98691381 not registered Live/Pending |
OASIS CONSUMER HEALTHCARE LLC. 2024-08-09 |
![]() HALO 98685312 not registered Live/Pending |
ECD Lacrosse, Inc. 2024-08-06 |
![]() HALO 98678393 not registered Live/Pending |
Metsera, Inc. 2024-08-01 |
![]() HALO 98636398 not registered Live/Pending |
Seats Incorporated 2024-07-08 |
![]() HALO 98624804 not registered Live/Pending |
Samtec Inc. 2024-06-28 |
![]() HALO 98550340 not registered Live/Pending |
SYDUCT DIAGNOSTICS INC. 2024-05-14 |
![]() HALO 98529116 not registered Live/Pending |
WH Products, LLC 2024-05-01 |
![]() HALO 98473348 not registered Live/Pending |
Ultradent Products, Inc. 2024-03-28 |
![]() HALO 98454522 not registered Live/Pending |
Halo, Inc. 2024-03-18 |
![]() HALO 98404978 not registered Live/Pending |
Prophetic, Inc. 2024-02-14 |
![]() HALO 98398702 not registered Live/Pending |
Halo Water Systems, LLC 2024-02-08 |
![]() HALO 98381032 not registered Live/Pending |
CenTex Aerospace, Inc. 2024-01-29 |