FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIAGNOSTIC DILATATION & MENSTRUAL KIT
K Number: K840384
·
Decision Apr 30, 1984
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
23
Applicant Total
5
Review Days
91
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Basic Information
- Device Name
- DIAGNOSTIC DILATATION & MENSTRUAL KIT
- K Number
- K840384
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5070
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Intl. Medical Technologies, Inc.
- Date Received
- January 30, 1984
- Decision Date
- April 30, 1984
- Product Code
- HHI
- 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 |
|---|---|---|---|
| HHI | System, Abortion, Vacuum | FDA class 2 | Obstetrics/Gynecology |
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