510(k) K984345
K984345 is an FDA 510(k) premarket notification submitted by Envis, Inc. for the device "AROMAPATCH". The FDA issued a decision of Substantially Equivalent on March 19, 1999. The device falls under product code LRD (Applicator, Ent Drug), a Class I device regulated under 21 CFR 874.5220.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 1999
- Date Received
- December 4, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ent Drug
- Device Class
- Class I
- Regulation Number
- 874.5220
- Review Panel
- EN
- Submission Type