510(k) K971434
K971434 is an FDA 510(k) premarket notification submitted by Applied Medical Technologies for the device "A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE". The FDA issued a decision of Substantially Equivalent on August 17, 1998. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Applied Medical Technologies has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 1998
- Date Received
- April 18, 1997
- 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