FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATTON SPECULUM
K Number: K991963
·
Decision Sep 1, 1999
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
4
Review Days
83
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Basic Information
- Device Name
- PATTON SPECULUM
- K Number
- K991963
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Patton Medical Corp.
- Date Received
- June 10, 1999
- Decision Date
- September 1, 1999
- Product Code
- HIB
- 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 |
|---|---|---|---|
| HIB | Speculum, Vaginal, Nonmetal | FDA class 2 | Obstetrics/Gynecology |
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