510(k) K033245
K033245 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U". The FDA issued a decision of Substantially Equivalent on November 6, 2003. The device falls under product code MND (Ligator, Esophageal), a Class II device regulated under 21 CFR 876.4400. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 6, 2003
- Date Received
- October 7, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ligator, Esophageal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type