The following data is part of a premarket notification filed by Teikoku Pharma Usa, Inc. with the FDA for Envela (hydrohesive Occlusive Dressing).
| Device ID | K072560 |
| 510k Number | K072560 |
| Device Name: | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) |
| Classification | Dressing, Wound, Occlusive |
| Applicant | TEIKOKU PHARMA USA, INC. 1718 RINGWOOD AVE. San Jose, CA 95131 -1711 |
| Contact | Margie Nemcik-cruz |
| Correspondent | Margie Nemcik-cruz TEIKOKU PHARMA USA, INC. 1718 RINGWOOD AVE. San Jose, CA 95131 -1711 |
| Product Code | NAD |
| CFR Regulation Number | 878.4020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-11 |
| Decision Date | 2008-06-17 |
| Summary: | summary |