510(k) K884379
K884379 is an FDA 510(k) premarket notification submitted by Lafayette Pharmacal, Inc. for the device "MAGLINTE ENTEROCLYSIS CATHETER". The FDA issued a decision of Substantially Equivalent on February 28, 1989. The device falls under product code FGD (Catheter, Retention, Barium Enema With Bag), 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
- SESE (Substantially Equivalent)
- Decision Date
- February 28, 1989
- Date Received
- October 18, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Retention, Barium Enema With Bag
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type