FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
K Number: K963685
·
Decision Oct 11, 1996
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
72
Applicant Total
3
Review Days
38
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Basic Information
- Device Name
- EOS BRAND DISPOSABLE CYTO/CERVICAL SAMPLER
- K Number
- K963685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- North Eos Industries, Inc.
- Date Received
- September 3, 1996
- Decision Date
- October 11, 1996
- Product Code
- HHT
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHT | Spatula, Cervical, Cytological | FDA class 2 | Obstetrics/Gynecology |
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