FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DOWD(TM) II
K Number: K922349
·
Decision Aug 14, 1992
Classifications
1
FEI Numbers
67
Registration Numbers
67
Same Product Code
26
Applicant Total
430
Review Days
87
Basic Information
- Device Name
- DOWD(TM) II
- K Number
- K922349
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5520
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BOSTON SCIENTIFIC CORP.
- Date Received
- May 19, 1992
- Decision Date
- August 14, 1992
- Product Code
- KOE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KOE | Dilator, Urethral | FDA class 2 | Gastroenterology, Urology |
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