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 Number: 9612018
• FEI Number: 3002809487
• Name: Takahiro Haruyama
• Owner & Operator: SAN-M PACKAGE CO., LTD.
• Contact Address: 1086-1 OJIRO ; SHIMADA JP-22 Sizuoka 428-0009 JP
• Official Correspondent:
  • KAORU - MIYAKE
  • 81-547-454125-x
• US Agent:
  • Takahiro Haruyama
  • Globizz Corporation
  • 310 5383860
  • register@globizz.net
• Importing Logistics Registration:
  • Importer: MOLNLYCKE HEALTH CARE, US LLC
  • Address: 100 SCHMID PLAZA RD ; AND, SC 29624 UNITED STATES
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1411 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	Device	Date
PMN K221534 San-M Package Co., Ltd.	Surgical Face Masks (Ear Loops And Tie-On)	2022-09-16
PMN K160271 | MSH Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	N95 Respirator	2020-03-26
PMN K160269 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	Surgical Level3	2020-03-26
PMN K160269 SAN-M PACKAGE CO., LTD.	Surgical Face Masks (Ear Loops And Tie-on)	2016-09-06
PMN K160271 SAN-M PACKAGE CO., LTD.	N95 Particulate Respirator And Surgical Mask, Models TN01-11 And TN01-12	2016-07-15
PMN K934194 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	BARRIER Laser Plume Face Mask	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SURGINE II Soft Arch Mask	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SURGINE II Face Mask	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SURGINE II Anti-Fog Mask	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SOFLOOP Extra ProtectionPlus Face M	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SOFLOOP Extra Protection Face Mask	2008-02-26
PMN K920108 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	BARRIER Extra Protection Face Mask	2008-02-26
PMN K910557 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	SOFLOOP Extra Protection Plus Face	2008-02-26
PMN K910557 | FXX Takahiro Haruyama [SAN-M PACKAGE CO., LTD.]	BARRIER Extra Protection Plus Face	2008-02-26

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
202009195840	Singapore,Singapore -> Charleston, South Carolina	SURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42391-02 REF 42341-01 REF 42361-01 REF 42241-01	912 PCS
2020081030536	Pusan,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 ARRANGED	1834 PCS
2020080334662	Pusan,South Korea -> Charleston, South Carolina	------------ TGHU1350680 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42391-02 REF 42341-01	949 PCS
2020062923648	Pusan,South Korea -> Charleston, South Carolina	------------ CMAU6532371 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 REF 42311-01 REF 42381-01 REF 42391-02	2184 PCS
202006159048	Pusan,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 ARRANGED	270 PCS
2020051823159	Pusan,South Korea -> Charleston, South Carolina	------------ CMAU7184202 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42381-01 42391-02	1997 PCS
2020050427379	Pusan,South Korea -> Charleston, South Carolina	------------ GESU1047413 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42391-02 42341-01	598 PCS
202004279028	Shanghai ,China (Mainland) -> Charleston, South Carolina	------------ TCLU3065467 DESCRIPTION--------- -------------GENERIC DESCRIPTION------------- SURGICAL FACE MASKS REF 42301-01 42311-01 42381-01 42391-02	904 PCS