510(k) K800610
K800610 is an FDA 510(k) premarket notification submitted by G.D. Searle And Co. for the device "URETHRAL SOUND". The FDA issued a decision of Substantially Equivalent on Apr 8, 1980. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. G.D. Searle And Co. has 55 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 8, 1980
- Date Received
- Mar 17, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dilator, Urethral
- Device Class
- Class II
- Regulation Number
- 876.5520
- Review Panel
- GU
- Submission Type
- 510(k) Exempt