510(k) K990389
K990389 is an FDA 510(k) premarket notification submitted by Moss Tubes, Inc. for the device "MOSS GASTROSTOMY TUBE". The FDA issued a decision of Substantially Equivalent on March 22, 1999. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Moss Tubes, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1999
- Date Received
- February 8, 1999
- 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