The following data is part of a premarket notification filed by Alcavis International, Inc. with the FDA for Exsept Wc Wound Cleanser.
| Device ID | K061467 |
| 510k Number | K061467 |
| Device Name: | EXSEPT WC WOUND CLEANSER |
| Classification | Dressing, Wound, Drug |
| Applicant | ALCAVIS INTERNATIONAL, INC. 8322 HELGERMAN COURT Gaithersburg, MD 20877 |
| Contact | Gary J Mishkin |
| Correspondent | Gary J Mishkin ALCAVIS INTERNATIONAL, INC. 8322 HELGERMAN COURT Gaithersburg, MD 20877 |
| 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 | 2006-05-26 |
| Decision Date | 2007-02-15 |
| Summary: | summary |