510(k) K052797
K052797 is an FDA 510(k) premarket notification submitted by Medtek Devices, Inc. for the device "LAPEVAC, FILTRATION DEVICE FOR THE PERIOTONEUM". The FDA issued a decision of Substantially Equivalent on February 13, 2006. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. Medtek Devices, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 13, 2006
- Date Received
- October 3, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Exhaust, Surgical
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type