510(k) K022434
K022434 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 August 5, 2002. 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
- August 5, 2002
- Date Received
- July 25, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Ligator, Esophageal
- Device Class
- Class II
- Regulation Number
- 876.4400
- Review Panel
- GU
- Submission Type