DOWD(TM) II
FDA 510(k) clearance K922349 · decided 1992-08-14
Clearance details
- K-number
- K922349
- Device name
- DOWD(TM) II
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1992-05-19
- Decision date
- 1992-08-14
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- KOE
- Device class
- 2
- Regulation number
- 876.5520
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.