510(k) K082472
K082472 is an FDA 510(k) premarket notification submitted by Medical Wire & Equipment Company (Bath), Ltd. for the device "VIROCULT, MODEL MW950". The FDA issued a decision of Substantially Equivalent on December 30, 2008. The device falls under product code LIO (Device, Specimen Collection), a Class I device regulated under 21 CFR 866.2900. Medical Wire & Equipment Company (Bath), Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 2008
- Date Received
- August 28, 2008
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Specimen Collection
- Device Class
- Class I
- Regulation Number
- 866.2900
- Review Panel
- MI
- Submission Type