510(k) K070783
K070783 is an FDA 510(k) premarket notification submitted by Sopro for the device "SOPRO MODEL 640 LAPAROSCOPIC INSUFFLATOR". The FDA issued a decision of Substantially Equivalent on December 13, 2007. The device falls under product code HIF (Insufflator, Laparoscopic), a Class II device regulated under 21 CFR 884.1730. Sopro has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2007
- Date Received
- March 21, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Insufflator, Laparoscopic
- Device Class
- Class II
- Regulation Number
- 884.1730
- Review Panel
- OB
- Submission Type