510(k) K952565
K952565 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "LYOFOAM EXTRA". The FDA issued a decision of SN on November 14, 1995. The device falls under product code KMF (Bandage, Liquid), a Class I device regulated under 21 CFR 880.5090. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- November 14, 1995
- Date Received
- June 2, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bandage, Liquid
- Device Class
- Class I
- Regulation Number
- 880.5090
- Review Panel
- SU
- Submission Type