510(k) K881162
K881162 is an FDA 510(k) premarket notification submitted by Smash Ent., Inc. for the device "ENTERA* ENTERAL FEEDING BAG". The FDA issued a decision of Substantially Equivalent on June 3, 1988. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Smash Ent., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 3, 1988
- Date Received
- March 18, 1988
- 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