The following data is part of a premarket notification filed by Huizhou Foryou Medical Devices Co., Ltd. with the FDA for Luofucon Silicone Ag Foam Dressing.
Device ID | K160022 |
510k Number | K160022 |
Device Name: | LUOFUCON Silicone Ag Foam Dressing |
Classification | Dressing, Wound, Drug |
Applicant | HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA ROAD DONGJIANG HI-TECH INDUSTRY PARK Huizhou, CN 516005 |
Contact | Guosheng Tan |
Correspondent | Guosheng Tan HUIZHOU FORYOU MEDICAL DEVICES Co., Ltd. NORTH SHANGXIA ROAD DONGJIANG HI-TECH INDUSTRY PARK Huizhou, CN 516005 |
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 | 2016-01-05 |
Decision Date | 2016-08-17 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00714196932730 | K160022 | 000 |
04063591428208 | K160022 | 000 |
04063591428246 | K160022 | 000 |
04063591428291 | K160022 | 000 |
04063591428321 | K160022 | 000 |
04063591428376 | K160022 | 000 |
00714196391025 | K160022 | 000 |
00714196391049 | K160022 | 000 |
00714196391063 | K160022 | 000 |
00714196492203 | K160022 | 000 |
00714196494504 | K160022 | 000 |
00714196496607 | K160022 | 000 |
00714196932723 | K160022 | 000 |
00324357020444 | K160022 | 000 |