This page includes the latest FDA filings for Columbia Healthcare Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3012344491 |
| FEI Number | 3012344491 |
| Name | COLUMBIA HEALTHCARE, INC. |
| Owner & Operator | Columbia Healthcare, Inc. |
| Contact Address | 103-810, 38, Uisadang-daero, Yeongdeungpo-gu Seoul KR-11 Seoul Teugbyeolsi 150-916 KR |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | RM 604, 53, Gasan Digital 2-ro Geuncheon-gu, Seoul Seoul Teugbyeolsi, 08588 KR |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
COLUMBIA HEALTHCARE, INC. | VertaLoc Pro Ankle Brace | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | Ankle Brace | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | VertaLoc DynaLite | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | Knee Brace | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | VertaLoc Flex Fit | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | VertaLoc Flex Fit Plus | 2016-03-11 |
COLUMBIA HEALTHCARE, INC. | Back Brace | 2016-03-11 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020082815589 | Pusan,South Korea -> Miami, Florida | INFINITY G5 STRIPS(50) INFINIT Y G5 STARTER KIT INFINITY G5 METER KIT EASYGLUCO G2 STRIPS( 50) INFINITY G5 NORMAL CONTROL SOLUTION INFINITY G5 LOW CON TROL SOLUTION INFINITY G5 HIGH CONTROL SOLUTION US DIAGNOSTI | 327 CTN |
| 2020072510686 | Pusan,South Korea -> Miami, Florida | INFINITY G5 STRIPS(50) INFINIT Y G5 STARTER KIT INFINITY G5 M ETER KIT EASYGLUCO G2 STRIPS(5 0) | 159 CTN |
| 202006085689 | Pusan,South Korea -> Miami, Florida | INFINITY G5 STRIPS(50) INFINIT Y G5 STARTER KIT INFINITY G5 M ETER KIT EASYGLUCO G2 STRIPS(5 0) INFINITY G5 HIGH CONTROL SO LUTION INFINITY G5 LOW CONTROL SOLUTION EASYGLUCO G2 NORMAL CONTROL SOLUTION | 231 CTN |
| 2019092756743 | Pusan,South Korea -> Los Angeles, California | OTHER CARE OF SKIN PEELING GEL | 3 PKG |
| 201909167658 | Pusan,South Korea -> Miami, Florida | INFINITY G5 METER KIT INFINITY G5 STRIPS(50) US DIAGNOSTICS SINGLE-USE SAFETY LANCETS VER TALOC FLEX FIT - L0648 - MEDI UM (36" - 40") VERTALOC FLEX F IT - L0648 - LARGE (41" - 44" ) VERTALOC FLEX FIT - L0648 - | 144 CTN |
| 2019071511743 | Pusan,South Korea -> Miami, Florida | INFINITY G5 METER KIT INFINITY G5 METER FOR REPLACEMENT INFI NITY G5 STARTER KIT EASYGLUCO G2 STARTER KIT EASYGLUCO G2 ST RIPS(50) EASYGLUCO G2 NORMAL C ONTROL SOLUTION US DIAGNOSTIC S LANCING DEVICE WITH INNER B | 126 CTN |
| 201905067417 | Pusan,South Korea -> Miami, Florida | INFINITY G5 METER KIT INFINITY G5 STRIPS(50) INFINITY G5 STR IPS(50) US DIAGNOSTICS LANCING DEVICE WITH POLYBAG US DIAGN OSTICS SINGLE-USE SAFETY LANC ETS VERTALOC MAX OA KNEE BRACE - XLARGE LEFT VERTALOC MAX O | 352 CTN |
| 201903084335 | Shanghai ,China (Mainland) -> Miami, Florida | ANKLE BRACE | 50 CTN |