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 |