FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL #53110 DISPOSABLE ANOSCOPE
K Number: K810227
·
Decision Feb 19, 1981
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
26
Applicant Total
111
Review Days
23
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Basic Information
- Device Name
- MODEL #53110 DISPOSABLE ANOSCOPE
- K Number
- K810227
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Welch Allyn, Inc.
- Date Received
- January 27, 1981
- Decision Date
- February 19, 1981
- Product Code
- FER
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| FER | Anoscope And Accessories | FDA class 2 | Gastroenterology, Urology |
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