FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
K Number: K061937
·
Decision Dec 1, 2006
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
39
Applicant Total
4
Review Days
144
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Basic Information
- Device Name
- COOK ENDOSCOPY ESOPHAGEAL DILATION BALLOON
- K Number
- K061937
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5365
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cook Endoscopy
- Date Received
- July 10, 2006
- Decision Date
- December 1, 2006
- Product Code
- KNQ
- 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 |
|---|---|---|---|
| KNQ | Dilator, Esophageal | FDA class 2 | Gastroenterology, Urology |
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