FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
O.N.A.T.
K Number: K820175
·
Decision Jan 29, 1982
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
25
Applicant Total
3
Review Days
8
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Basic Information
- Device Name
- O.N.A.T.
- K Number
- K820175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4900
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Latex Medical Devices, Inc.
- Date Received
- January 21, 1982
- Decision Date
- January 29, 1982
- Product Code
- KNC
- 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 |
|---|---|---|---|
| KNC | Table, Obstetric (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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