San M Package Co L T D

FDA Filings

This page includes the latest FDA filings for San M Package Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9612018
FEI Number3002809487
NameTakahiro Haruyama
Owner & OperatorSAN-M PACKAGE CO., LTD.
Contact Address1086-1 OJIRO
SHIMADA JP-22 Sizuoka 428-0009 JP
Official Correspondent
  • KAORU - MIYAKE
  • 81-547-454125-x
US Agent
Importing Logistics Registration
ImporterMOLNLYCKE HEALTH CARE, US LLC
Address100 SCHMID PLAZA RD
AND, SC 29624 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1411 W. 190th St. Toyota Plaza #200,
Gardena, CA 90248 US
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
San-M Package Co., Ltd.
Surgical Face Masks (Ear Loops And Tie-On)2022-09-16
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
N95 Respirator2020-03-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
Surgical Level32020-03-26
SAN-M PACKAGE CO., LTD.
Surgical Face Masks (Ear Loops And Tie-on)2016-09-06
SAN-M PACKAGE CO., LTD.
N95 Particulate Respirator And Surgical Mask, Models TN01-11 And TN01-122016-07-15
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
BARRIER Laser Plume Face Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SURGINE II Soft Arch Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SURGINE II Face Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SURGINE II Anti-Fog Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SOFLOOP Extra ProtectionPlus Face M2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SOFLOOP Extra Protection Face Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
BARRIER Extra Protection Face Mask2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
SOFLOOP Extra Protection Plus Face2008-02-26
Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]
BARRIER Extra Protection Plus Face2008-02-26

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202009195840Singapore,Singapore -> Charleston, South CarolinaSURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42391-02 REF 42341-01 REF 42361-01 REF 42241-01912 PCS
2020081030536Pusan,South Korea -> Charleston, South Carolina------------ CMAU9091897 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42381-01 REF 42281-01 HS CODE: 6307.90 FREIGHT COLLECT AS ARRANGED1834 PCS
2020080334662Pusan,South Korea -> Charleston, South Carolina------------ TGHU1350680 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42391-02 REF 42341-01949 PCS
2020062923648Pusan,South Korea -> Charleston, South Carolina------------ CMAU6532371 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42381-01 REF 42391-022184 PCS
202006159048Pusan,South Korea -> Charleston, South Carolina------------ CMAU1817860 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42381-01 REF 42241-01 HS CODE: 6307.90 FREIGHT COLLECT AS ARRANGED270 PCS
2020051823159Pusan,South Korea -> Charleston, South Carolina------------ CMAU7184202 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42381-01 42391-021997 PCS
2020050427379Pusan,South Korea -> Charleston, South Carolina------------ GESU1047413 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42391-02 42341-01598 PCS
202004279028Shanghai ,China (Mainland) -> Charleston, South Carolina------------ TCLU3065467 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42381-01 42391-02904 PCS

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