FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DRAINAGE BAG
K Number: K990428
·
Decision Aug 12, 1999
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
8
Applicant Total
19
Review Days
182
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Basic Information
- Device Name
- DRAINAGE BAG
- K Number
- K990428
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remington Medical, Inc.
- Date Received
- February 11, 1999
- Decision Date
- August 12, 1999
- Product Code
- EXF
- 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 |
|---|---|---|---|
| EXF | Bag, Bile Collecting | FDA class 2 | Gastroenterology, Urology |
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