510(k) K850019
K850019 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "OMNI PHASE PENILE PROSTHESIS". The FDA issued a decision of Substantially Equivalent on April 9, 1985. The device falls under product code FAE (Prosthesis, Penile), a Class II device regulated under 21 CFR 876.3630. Dacomed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1985
- Date Received
- January 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Penile
- Device Class
- Class II
- Regulation Number
- 876.3630
- Review Panel
- GU
- Submission Type