510(k) K830667
K830667 is an FDA 510(k) premarket notification submitted by Dacomed Corp. for the device "SILICONE-SILVER PENILE PROSTHESIS-ESK". The FDA issued a decision of Substantially Equivalent on October 20, 1983. The device falls under product code FTQ (Prosthesis, Penis, Rigid Rod), 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
- October 20, 1983
- Date Received
- March 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Penis, Rigid Rod
- Device Class
- Class II
- Regulation Number
- 876.3630
- Review Panel
- GU
- Submission Type