The following data is part of a premarket notification filed by Advanced Medical Solutions Ltd. with the FDA for Surgical Silver Post Operative Dressing.
Device ID | K180634 |
510k Number | K180634 |
Device Name: | Surgical Silver Post Operative Dressing |
Classification | Dressing, Wound, Drug |
Applicant | Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford, GB Cw7 3rt |
Contact | Rose Guang |
Correspondent | Rose Guang Advanced Medical Solutions Ltd. Premier Park, 33 Road One, Winsford Industrial Estate Winsford, GB Cw7 3rt |
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 | 2018-03-12 |
Decision Date | 2018-08-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888277717138 | K180634 | 000 |
15032749025022 | K180634 | 000 |
15032749025039 | K180634 | 000 |
15032749025046 | K180634 | 000 |
15032749025053 | K180634 | 000 |
15032749025060 | K180634 | 000 |
15032749027439 | K180634 | 000 |
10193489020182 | K180634 | 000 |
10888277717091 | K180634 | 000 |
10888277717107 | K180634 | 000 |
10888277717114 | K180634 | 000 |
10888277717121 | K180634 | 000 |
15032749025015 | K180634 | 000 |