510(k) K022979
K022979 is an FDA 510(k) premarket notification submitted by Instruments Medicaux G.B., Inc. for the device "LAPARETTE, MODEL LAP J L S H N". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code KNF (Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4160. Instruments Medicaux G.B., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2002
- Date Received
- September 9, 2002
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4160
- Review Panel
- OB
- Submission Type