510(k) K860441
K860441 is an FDA 510(k) premarket notification submitted by Lafayette Pharmacal, Inc. for the device "ENTROKIT WITH MAGLINTE CATHETER". The FDA issued a decision of Substantially Equivalent (with conditions) on March 12, 1986. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Lafayette Pharmacal, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- March 12, 1986
- Date Received
- February 4, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Gastro-Enterostomy
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type