FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AN-10S ANDERSEN TUBE WITH STYLET
K Number: K935688
·
Decision Dec 30, 1994
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
12
Applicant Total
5
Review Days
396
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Basic Information
- Device Name
- AN-10S ANDERSEN TUBE WITH STYLET
- K Number
- K935688
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- H.W. Andersen Products, Inc.
- Date Received
- November 29, 1993
- Decision Date
- December 30, 1994
- Product Code
- BSS
- 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 |
|---|---|---|---|
| BSS | Tube, Nasogastric | FDA class 2 | Gastroenterology, Urology |
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