510(k) K933957
K933957 is an FDA 510(k) premarket notification submitted by Cook Urological, Inc. for the device "DILATING URETHRAL SOUND". The FDA issued a decision of Substantially Equivalent on November 17, 1993. The device falls under product code FAH (Dilator, Urethral, Mechanical), a Class II device regulated under 21 CFR 876.5520. Cook Urological, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1993
- Date Received
- August 12, 1993
- 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