510(k) K141619

LUOFUCON SILVER FOAM DRESSING by Huizhou Foryou Medical Devices Co., Ltd. — Product Code FRO

K141619 is an FDA 510(k) premarket notification submitted by Huizhou Foryou Medical Devices Co., Ltd. for the device "LUOFUCON SILVER FOAM DRESSING". The FDA issued a decision of Substantially Equivalent on April 6, 2015. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Huizhou Foryou Medical Devices Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2015
Date Received
June 17, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type