510(k) K073718
K073718 is an FDA 510(k) premarket notification submitted by Medline Industries, Inc. for the device "MEDLINE GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on March 19, 2008. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Medline Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 19, 2008
- Date Received
- December 31, 2007
- Clearance Type
- Abbreviated
- 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