The following data is part of a premarket notification filed by Entegrion, Inc. with the FDA for Stasilon Fr.
| Device ID | K072890 |
| 510k Number | K072890 |
| Device Name: | STASILON FR |
| Classification | Dressing, Wound, Drug |
| Applicant | ENTEGRION, INC. 79 TW ALEXANDER DRIVE SUITE 20 4401 RESEARCH COMMONS Research Triangle Park, NC 27709 |
| Contact | E.s. Eskridge, Jr. |
| Correspondent | E.s. Eskridge, Jr. ENTEGRION, INC. 79 TW ALEXANDER DRIVE SUITE 20 4401 RESEARCH COMMONS Research Triangle Park, NC 27709 |
| 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 | 2007-10-10 |
| Decision Date | 2007-12-10 |
| Summary: | summary |