510(k) K182725
K182725 is an FDA 510(k) premarket notification submitted by Sweetbio, Inc. for the device "Apis". The FDA issued a decision of Substantially Equivalent on May 31, 2019. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Sweetbio, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 31, 2019
- Date Received
- September 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dressing, Wound, Drug
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type