FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
K Number: K981286
·
Decision Jun 19, 1998
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
22
Applicant Total
4
Review Days
72
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Basic Information
- Device Name
- SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS
- K Number
- K981286
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Armm, Inc.
- Date Received
- April 8, 1998
- Decision Date
- June 19, 1998
- Product Code
- KDH
- 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 |
|---|---|---|---|
| KDH | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration | FDA class 2 | Gastroenterology, Urology |
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