Unilene Sac

FDA Filings

This page includes the latest FDA filings for Unilene Sac. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

Registration Number

3004845555

FEI Number

3004845555

Name

UNILENE, SAC

Owner & Operator

Unilene, SAC

Contact Address

Napo 450
Lima 05 PE-LIM Lima 05 PE

Official Correspondent

Martha Lujan
51-511-3323206-408

US Agent

Louis Sun
Sutumed Corp.
256 6583388
305 7413388
louis.sun338@gmail.com

Importing Logistics Registration

Importer	Sutumed Corp
Address	9280 College Parkway Suite 5 Fort Myers, FL 33919 UNITED STATES
Email Address	marthalujan@unilene.com
Phone	1 239 8887805

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Napo 450
Lima 05 Lima, 05 PE

Establishment Type

Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K123034 \| GAW UNILENE, SAC	Unilene Non Absorbable Suture	2013-06-04
PMN K123034 \| GAW UNILENE, SAC	Unilene Absorbable Suture	2013-06-04
PMN K123034 \| GAR UNILENE, SAC	Unilene Non Absorbable Suture	2013-06-04
PMN K123034 \| GAR UNILENE, SAC	Unilene Absorbable Suture	2013-06-04
PMN K123034 \| GAP UNILENE, SAC	Unilene Non Absorbable Suture	2013-06-04
PMN K123034 \| GAP UNILENE, SAC	Unilene Absorbable Suture	2013-06-04
PMN K100780 \| NEW UNILENE, SAC	Unilene Absorbable Suture	2011-01-25
PMN K100780 \| GAN UNILENE, SAC	Unilene Absorbable Suture	2011-01-25
PMN K100780 \| GAM UNILENE, SAC	Unilene Absorbable Suture	2011-01-25

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