The following data is part of a premarket notification filed by Envis, Inc. with the FDA for Aromapatch.
| Device ID | K984345 |
| 510k Number | K984345 |
| Device Name: | AROMAPATCH |
| Classification | Applicator, Ent Drug |
| Applicant | ENVIS, INC. 25 HERTIAGE DR. Asheville, NC 28806 |
| Contact | Steve Woody |
| Correspondent | Steve Woody ENVIS, INC. 25 HERTIAGE DR. Asheville, NC 28806 |
| Product Code | LRD |
| CFR Regulation Number | 874.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-04 |
| Decision Date | 1999-03-19 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AROMAPATCH 87264400 not registered Dead/Abandoned |
Nelly Packs 2016-12-10 |