510(k) K831384
K831384 is an FDA 510(k) premarket notification submitted by Thomas J. Fogarty, M.D. for the device "COAXIAL BALLOON URETHRAL DILATOR". The FDA issued a decision of Substantially Equivalent on July 26, 1983. The device falls under product code FAH (Dilator, Urethral, Mechanical), a Class II device regulated under 21 CFR 876.5520. Thomas J. Fogarty, M.D. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 1983
- Date Received
- April 28, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Urethral, Mechanical
- Device Class
- Class II
- Regulation Number
- 876.5520
- Review Panel
- GU
- Submission Type