510(k) K000507
K000507 is an FDA 510(k) premarket notification submitted by Uromed Corp. for the device "CAVERMAP SURGICAL AID". The FDA issued a decision of Substantially Equivalent on April 21, 2000. The device falls under product code ETN (Stimulator, Nerve), a Class II device regulated under 21 CFR 874.1820. Uromed Corp. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 21, 2000
- Date Received
- February 15, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve
- Device Class
- Class II
- Regulation Number
- 874.1820
- Review Panel
- EN
- Submission Type