510(k) K864084
K864084 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "LYOFOAM C ODOR-ABSORBING DRESSING". The FDA issued a decision of SN on November 21, 1986. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 21, 1986
- Date Received
- October 20, 1986
- 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