STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE

Suture, Nonabsorbable, Synthetic, Polypropylene

INTERNACIONAL FARMACEUTICA, S.A. DE C.V.

The following data is part of a premarket notification filed by Internacional Farmaceutica, S.a. De C.v. with the FDA for Sterile Polypropylene Monfil Nonabsorb Surg Suture.

Pre-market Notification Details

• Device ID: K911189
• 510k Number: K911189
• Device Name: STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
• Classification: Suture, Nonabsorbable, Synthetic, Polypropylene
• Applicant: INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021
• Contact: Alan P Schwartz
• Correspondent: Alan P Schwartz; INTERNACIONAL FARMACEUTICA, S.A. DE C.V. C/O MEDICAL DEVICE INSPECTION 55 NORTHERN BOULEVARD, STE 301 Great Neck, NY 11021
• Product Code: GAW
• CFR Regulation Number: 878.5010 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-03-18
• Decision Date: 1991-04-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07500142114014	K911189	000
07500142105432	K911189	000
07500142105104	K911189	000
07500142103988	K911189	000
07500142103773	K911189	000
07500142103766	K911189	000
07500142103216	K911189	000
07500142103209	K911189	000
07500142102929	K911189	000
07500142102684	K911189	000
07500142102677	K911189	000
07500142102493	K911189	000
07500142102486	K911189	000
07500142102325	K911189	000
07500142102158	K911189	000
07500142102004	K911189	000
07500142105739	K911189	000
07500142105753	K911189	000
07500142108938	K911189	000
07500142114007	K911189	000
07500142112959	K911189	000
07500142109645	K911189	000
07500142109546	K911189	000
07500142109522	K911189	000
07500142109515	K911189	000
07500142109478	K911189	000
07500142109393	K911189	000
07500142109386	K911189	000
07500142109379	K911189	000
07500142109256	K911189	000
07500142109232	K911189	000
07500142109201	K911189	000
07500142109195	K911189	000
07500142108983	K911189	000
07500142101991	K911189	000
07500142101960	K911189	000
07500142156601	K911189	000
07500142156595	K911189	000
07500142152078	K911189	000
07500142109669	K911189	000
07500142109454	K911189	000
07500142108969	K911189	000
07500142108877	K911189	000
07500142104862	K911189	000
07500142103810	K911189	000
07500142103759	K911189	000
07500142103698	K911189	000
07500142103360	K911189	000
07500142101984	K911189	000
07500142101236	K911189	000
07500142100413	K911189	000
07500142156632	K911189	000
07500142042379	K911189	000
07500142100222	K911189	000
07500142101946	K911189	000
07500142101724	K911189	000
07500142101601	K911189	000
07500142101533	K911189	000
07500142101526	K911189	000
07500142101175	K911189	000
07500142101144	K911189	000
07500142101113	K911189	000
07500142100932	K911189	000
07500142100925	K911189	000
07500142100574	K911189	000
07500142100482	K911189	000
07500142100390	K911189	000
07500142100383	K911189	000
07500142100239	K911189	000
07500142109362	K911189	000
07500142114755	K911189	000
07500142055065	K911189	000
07500142180040	K911189	000
07500142180033	K911189	000
07500142180026	K911189	000
07500142180019	K911189	000
07500142179990	K911189	000
07500142179983	K911189	000
07500142179976	K911189	000
07500142179969	K911189	000
07500142179952	K911189	000
07500142179945	K911189	000
07500142179921	K911189	000
07500142179914	K911189	000
07500142179907	K911189	000
07500142179822	K911189	000
07500142179785	K911189	000
07500142180057	K911189	000
07500142180064	K911189	000
07500142180071	K911189	000
07500142180620	K911189	000
07500142180316	K911189	000
07500142180309	K911189	000
07500142180293	K911189	000
07500142180286	K911189	000
07500142180224	K911189	000
07500142180217	K911189	000
07500142180200	K911189	000
07500142180156	K911189	000
07500142180149	K911189	000
07500142180125	K911189	000
07500142180118	K911189	000
07500142180101	K911189	000
07500142180095	K911189	000
07500142180088	K911189	000
07500142168758	K911189	000
07500142168680	K911189	000
07500142155116	K911189	000
07500142154300	K911189	000
07500142045844	K911189	000
17500142042379	K911189	000
07500142131936	K911189	000
07500142129889	K911189	000
07500142129872	K911189	000
07500142129865	K911189	000
07500142129834	K911189	000
07500142127120	K911189	000
07500142126185	K911189	000
07500142125898	K911189	000
07500142125645	K911189	000
07500142120381	K911189	000
07500142117374	K911189	000
07500142156182	K911189	000
07500142156380	K911189	000
07500142156588	K911189	000
07500142168673	K911189	000
07500142168659	K911189	000
07500142168642	K911189	000
07500142168635	K911189	000
07500142161797	K911189	000
07500142157707	K911189	000
07500142156724	K911189	000
07500142156717	K911189	000
07500142156700	K911189	000
07500142156694	K911189	000
07500142156687	K911189	000
07500142156670	K911189	000
07500142156663	K911189	000
07500142156649	K911189	000
07500142156625	K911189	000
07500142116469	K911189	000