The following data is part of a premarket notification filed by Nanofiber Solutions, Inc. with the FDA for Phoenix Wound Matrix.
Device ID | K173544 |
510k Number | K173544 |
Device Name: | Phoenix Wound Matrix |
Classification | Dressing, Wound, Drug |
Applicant | Nanofiber Solutions, Inc. 4389 Weaver Court North Hilliard, OH 43026 |
Contact | Ronald L. Bracken |
Correspondent | Ronald L. Bracken Nanofiber Solutions, Inc. 4389 Weaver Court North Hilliard, OH 43026 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-16 |
Decision Date | 2018-03-02 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00852513007041 | K173544 | 000 |
00852513007249 | K173544 | 000 |
00852513007256 | K173544 | 000 |
00852513007263 | K173544 | 000 |
00852513007270 | K173544 | 000 |
00852513007287 | K173544 | 000 |
00852513007294 | K173544 | 000 |
00852513007300 | K173544 | 000 |
20852513007069 | K173544 | 000 |
20852513007076 | K173544 | 000 |
20852513007083 | K173544 | 000 |
20852513007090 | K173544 | 000 |
00852513007010 | K173544 | 000 |
00852513007027 | K173544 | 000 |
00852513007034 | K173544 | 000 |
00852513007232 | K173544 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PHOENIX WOUND MATRIX 87781650 not registered Dead/Abandoned |
Renovoderm 2018-02-02 |