FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENTEX DISPOSABLE VAGINAL SPECULUM
K Number: K030693
·
Decision Aug 27, 2003
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
71
Applicant Total
6
Review Days
175
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Basic Information
- Device Name
- KENTEX DISPOSABLE VAGINAL SPECULUM
- K Number
- K030693
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kentron Health Care, Inc.
- Date Received
- March 5, 2003
- Decision Date
- August 27, 2003
- 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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Other Clearances by Kentron Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972410 | IMPERVIOUS ISOLATION GOWN | Sep 19, 1997 | Substantially Equivalent |
| K971917 | KENTRON'S ISOLATION GOWN | Sep 19, 1997 | Substantially Equivalent |
| K953465 | KENTEMP | Dec 15, 1995 | Substantially Equivalent |
| K953914 | KENTEX | Nov 6, 1995 | Substantially Equivalent |
| K953830 | KENSORB | Oct 3, 1995 | Substantially Equivalent |