510(k) K940661
K940661 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "STIEGMANN-GOFF ENDOSCOPIC LIGATOR". The FDA issued a decision of Substantially Equivalent on November 28, 1994. 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 28, 1994
- Date Received
- February 15, 1994
- Clearance Type
- Traditional
- 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