510(k) K860818
K860818 is an FDA 510(k) premarket notification submitted by Acme United Corp. for the device "ONE TIME ENTERAL FEEDING BAG". The FDA issued a decision of Substantially Equivalent on May 15, 1986. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Acme United Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 1986
- Date Received
- March 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type