510(k) K905026
K905026 is an FDA 510(k) premarket notification submitted by Mmi, Inc. for the device "DUAL FLEX NON-LATEX". The FDA issued a decision of Substantially Equivalent on December 18, 1991. The device falls under product code FGD (Catheter, Retention, Barium Enema With Bag), a Class II device regulated under 21 CFR 876.5980. Mmi, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1991
- Date Received
- November 7, 1990
- 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