510(k) K861015
K861015 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "ONE TIME HYPERAL & CATHETER DRESSING CHANGE TRAYS". The FDA issued a decision of Substantially Equivalent on April 22, 1986. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1986
- Date Received
- March 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type