FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CERVICAL DILATOR
K Number: K811568
·
Decision Jul 16, 1981
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
5
Applicant Total
4
Review Days
42
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Basic Information
- Device Name
- CERVICAL DILATOR
- K Number
- K811568
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Gynemetrics, Inc.
- Date Received
- June 4, 1981
- Decision Date
- July 16, 1981
- Product Code
- HDQ
- 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 |
|---|---|---|---|
| HDQ | Dilator, Cervical, Fixed Size | FDA class 1 | Obstetrics/Gynecology |
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