FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
K Number: K852951
·
Decision Aug 27, 1985
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
30
Applicant Total
111
Review Days
47
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Basic Information
- Device Name
- WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
- K Number
- K852951
- 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
- July 11, 1985
- Decision Date
- August 27, 1985
- Product Code
- FCW
- 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 |
|---|---|---|---|
| FCW | Light Source, Fiberoptic, Routine | FDA class 2 | Gastroenterology, Urology |
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