LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM

Dressing, Wound, Drug

HUIZHOU FORYOU MEDICAL DEVICES CO, LTD

The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co, Ltd with the FDA for Lufucon Silver Alginate Dressing 50x50mm, Lufucon Silver Alginate Dressing 100x100mm, Lufucon Silver Dressing 200x100mm.

Pre-market Notification Details

• Device ID: K120181
• 510k Number: K120181
• Device Name: LUFUCON SILVER ALGINATE DRESSING 50X50MM, LUFUCON SILVER ALGINATE DRESSING 100X100MM, LUFUCON SILVER DRESSING 200X100MM
• Classification: Dressing, Wound, Drug
• Applicant: HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington, NJ 08534
• Contact: Chengyu Shen
• Correspondent: Chengyu Shen; HUIZHOU FORYOU MEDICAL DEVICES CO, LTD 5 CAREY STREET Pennington, NJ 08534
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2012-01-20
• Decision Date: 2013-02-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00819123010670	K120181	000
00324357060228	K120181	000
00324357060457	K120181	000
00324357060662	K120181	000
00324357060884	K120181	000
00810040130670	K120181	000
00819123010687	K120181	000
00819123010694	K120181	000
10819123010547	K120181	000
10819123010561	K120181	000
10819123010530	K120181	000
00324357060129	K120181	000