The following data is part of a premarket notification filed by Alcavis Hdc Llc with the FDA for Exsept Skin And Wound Cleanser With Antimicrobial Preservative.
| Device ID | K111313 |
| 510k Number | K111313 |
| Device Name: | EXSEPT SKIN AND WOUND CLEANSER WITH ANTIMICROBIAL PRESERVATIVE |
| Classification | Lavage, Jet |
| Applicant | ALCAVIS HDC LLC 8322 Helgerman CT Gaithersburg, MD 20877 |
| Contact | Gary J Mishkin |
| Correspondent | Gary J Mishkin ALCAVIS HDC LLC 8322 Helgerman CT Gaithersburg, MD 20877 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2011-05-10 |
| Decision Date | 2011-12-14 |
| Summary: | summary |