510(k) K922349
K922349 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "DOWD(TM) II". The FDA issued a decision of Substantially Equivalent on August 14, 1992. The device falls under product code KOE (Dilator, Urethral), a Class II device regulated under 21 CFR 876.5520. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 14, 1992
- Date Received
- May 19, 1992
- 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