The following data is part of a premarket notification filed by Stemsys with the FDA for Xcellistem Wound Powder.
| Device ID | K172593 |
| 510k Number | K172593 |
| Device Name: | XCelliStem Wound Powder |
| Classification | Dressing, Wound, Collagen |
| Applicant | StemSys 10871 NW 52nd St, Ste 4 Sunrise, FL 33351 |
| Contact | Clay Fette |
| Correspondent | Clay Fette StemSys 10871 NW 52nd St, Ste 4 Sunrise, FL 33351 |
| Product Code | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-29 |
| Decision Date | 2018-03-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00864567000336 | K172593 | 000 |
| 00864567000329 | K172593 | 000 |
| 00864567000312 | K172593 | 000 |