510(k) K042516
K042516 is an FDA 510(k) premarket notification submitted by Walter Lorenz Surgical, Inc. for the device "OTOMIMIX". The FDA issued a decision of Substantially Equivalent on November 8, 2004. The device falls under product code NEA (Cement, Ear, Nose And Throat), a Class II device regulated under 21 CFR 872.3275. Walter Lorenz Surgical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2004
- Date Received
- September 16, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cement, Ear, Nose And Throat
- Device Class
- Class II
- Regulation Number
- 872.3275
- Review Panel
- EN
- Submission Type